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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002596-34 | EudraCT Number |
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This randomized, double-blind, placebo-controlled, multiple-rising-dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8150 in healthy young men, in male participants with mild to moderate hypertension, in elderly male and female participants with mild to moderate hypertension, and in male and female participants with resistant hypertension. A primary study hypothesis is that there is at least one dose that does not increase heart rate (HR) to a clinically meaningful extent in male participants with mild to moderate hypertension and in elderly participants with mild to moderate hypertension on either Day 1 or the last Day of multiple dosing (Daylast), as measured by Time-weighted Average Across 24 hours (TWA0-24hrs). The hypothesis is met if mean increase (MK-8150 - placebo) in TWA0-24hrs HR in the identified groups is ≤15 beats per minute on Day 1 and Daylast.
Ten panels (Panels A-J), consisting of 103 participants in total, will be randomized to receive either MK-8150 or matching placebo.
Males (18 to 55 years of age, inclusive) with mild to moderate hypertension will be randomized in Panels A-D and will receive either MK-8150 or placebo as once daily treatment for 10 consecutive days.
Elderly males and females (65 to 80 years of age, inclusive) with mild to moderate hypertension will be included in Panels E and F and will receive a single dose of either MK-8150 or placebo on Study Day 1 followed by at least 5 days of wash-out before proceeding to once daily treatment of the same randomized treatment at a lower dose for 10 consecutive days.
Participants 18 to 65 years of age with resistant hypertension will be enrolled in Panels H and will receive in randomized sequences of MK-8150/placebo or placebo/MK-8150 in 2 treatment periods. There will be a minimum 3 weeks washout period between the 2 treatment periods in Panel H.
Healthy males (18 to 55 years of age, inclusive) will be enrolled in Panel G and will receive MK-8150 or matching placebo once daily for 28 days. Participants randomized to MK-8150 in Panel G who meet all of the dose-escalation criteria and have not met any of the hemodynamic stopping criteria will be eligible for dose increases on Day 8, Day 15, and Day 22. If dose escalation criteria are not met (or if the Investigator or Sponsor elects not to increase the dose), then the participant will continue on the current dose and will be eligible for a dose increase at the next dose-escalation decision day if all dose-escalation criteria are met at that time.
Male participants (18 to 65 years of age, inclusive) with mild to moderate hypertension will be randomized in Panels I and J. In each panel, 18 participants will receive either MK-8150 or matching placebo as once daily treatment for up to 28 consecutive days. Participants who are randomized to placebo will receive placebo throughout the study. On Days 8, 15 and 22 in both Panels I and J, participants will be eligible for dose-escalation, down-dosing, or continuing their current dose depending on their hemodynamic status. Participants in Panels I and J who meet down-dosing criteria at any time during the study will have their doses reduced to the previous well-tolerated dose level until the next dose-escalation decision day, or through the end of the study, whichever is first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A: Mild/Moderate Hypertension | Experimental | MK-8150 or matching placebo once daily, capsules, oral, for 10 days |
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| Panel B: Mild/Moderate Hypertension | Experimental | MK-8150 or matching placebo once daily, capsules, oral, for 10 days |
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| Panel C: Mild/Moderate Hypertension | Experimental | MK-8150 or matching placebo once daily, capsules, oral, for 10 days |
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| Panel D: Mild/Moderate Hypertension | Experimental | MK-8150 or matching placebo once daily, capsules, oral, for 10 days |
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| Panel E-Elderly | Experimental | Single dose of MK-8150 or placebo on Study Day 1 followed by a wash-out of at least 5 days, then MK-8150 or placebo once daily at a lower dose for 10 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8150 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. The 8 crossover Panel H participants are represented in both Panel H - MK-8150 10/20 mg column and Placebo (Panel A - J) column. | Up to 14 days after the last dose (Up to approximately 42 days, excluding pre-dose/screening period) |
| Number of Participants Discontinued From Study Drug Due to Meeting Hemodynamic Stopping Rules | Hemodynamic criteria for stopping drug dosing were applied (any of the following, obtained resting and if present for ≥1 hour, unless noted). For all Panels: HR >120 bpm; SBP ≥180 mm Hg (Panels A-D/G-J) and ≥175 mm Hg (Panels E-F); DBP ≥110 mm Hg; DBP <50 mm Hg; SBP <90 mm Hg or participant placed in Trendelenburg position. For Panels A-H: HR increase over identified baseline of ≥25 beats per minute; SBP reduction >30 mm Hg versus identified baseline; >20 mm Hg drop in SBP and >20 beats per minute rise in HR observed together versus identified baselines; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together. For Panels I-J, any of the following-down dosing criteria if still present 24 hours after dose decrease: HR increase ≥20 beats per minute versus identified baseline; SBP reduction >30 mm Hg versus identified baseline; SBP <100 mm Hg; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together. | Up to 28 days |
| Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27561272 | Result | Knox CD, de Kam PJ, Azer K, Wong P, Ederveen AG, Shevell D, Morabito C, Meehan AG, Liu W, Reynders T, Denef JF, Mitselos A, Jonathan D, Gutstein DE, Mitra K, Sun SY, Lo MM, Cully D, Ali A. Discovery and Clinical Evaluation of MK-8150, A Novel Nitric Oxide Donor With a Unique Mechanism of Nitric Oxide Release. J Am Heart Assoc. 2016 Aug 25;5(9):e003493. doi: 10.1161/JAHA.116.003493. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel A - Participants With Mild to Moderate Hypertension | 6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days |
| FG001 | Panel B - Participants With Mild to Moderate Hypertension | 6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days |
| FG002 | Panel C - Participants With Mild to Moderate Hypertension | 6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days |
| FG003 | Panel D - Participants With Mild to Moderate Hypertension | 5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days |
| FG004 | Panel E - Elderly Participants With Mild/Moderate Hypertension | 6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15 |
| FG005 | Panel F - Elderly Participants With Mild/Moderate Hypertension | 6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15 |
| FG006 | Panel G - Healthy Participants | 8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria |
| FG007 | Panel H - Participants With Resistant Hypertension | In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10 |
| FG008 | Panel I - Participants With Mild to Moderate Hypertension | 12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria |
| FG009 | Panel J - Participants With Mild to Moderate Hypertension | 12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel A - Participants With Mild to Moderate Hypertension | 6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days |
| BG001 | Panel B - Participants With Mild to Moderate Hypertension |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With an Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. The 8 crossover Panel H participants are represented in both Panel H - MK-8150 10/20 mg column and Placebo (Panel A - J) column. | All participants who received at least one dose of study drug | Posted | Number | participants | Up to 14 days after the last dose (Up to approximately 42 days, excluding pre-dose/screening period) |
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Up to 14 days after the last dose (Up to approximately 42 days, excluding pre-dose/screening period)
The 8 crossover Panel H participants are represented in both Panel H - MK-8150 10/20 mg column and Placebo (Panel A - J) column.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panel A - MK-8150 5 mg | MK-8150 5 mg once daily for 10 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postural orthostatic tachycardia syndrome | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000092244 | Isolated Systolic Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000075222 | Essential Hypertension |
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| ID | Term |
|---|---|
| C000625933 | MK-8150 |
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| Panel F - Elderly | Experimental | Single dose of MK-8150 or placebo on Study Day 1 followed by a wash-out of at least 5 days, then MK-8150 or placebo once daily at a lower dose for 10 days |
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| Panel G - Healthy - Dose Titration | Experimental | MK-8150 or matching placebo will be administered once daily for 28 days. Dose may be adjusted on Day 8, Day 15, and Day 22. |
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| Panel H - Crossover | Experimental | MK-8150 or matching placebo for 10 consecutive days in 2-period crossover with minimum 3 weeks washout period between the 2 treatment periods |
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| Panel I - Dose Titration | Experimental | MK-8150 or matching placebo will be administered once daily for 28 days. Dose may be adjusted on Day 8, Day 15, and Day 22. |
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| Panel J - Dose Titration | Experimental | MK-8150 or matching placebo will be administered once daily for 28 days. Dose may be adjusted on Day 8, Day 15, and Day 22. |
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| Placebo for MK-8150 | Drug |
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| Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs HR in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cSBP in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs HR in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose |
| Time to Maximum Observed Plasma Concentration (Tmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose |
| Apparent Terminal Half-life (t1/2) of MK-8150 Determined Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 was determined. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| t1/2 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the Day 1 dose. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 6 and Day 15 was determined. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose |
| Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose |
| t1/2 of MK-8150 Determined Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 15. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| AUC0-24 of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined. | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Cmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data. | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| Tmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data. | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| t1/2 of MK-8150 Determined Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| AUC0-24 of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Cmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose |
| Tmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose |
| t1/2 of MK-8150 Determined Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| AUC0-24 of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined. | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Cmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data. | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| Tmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data. | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| t1/2 of MK-8150 Determined Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28. | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
| Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs AIx in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value (determined separately in each period). | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs AIx Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
| Physician Decision |
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6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days |
| BG002 | Panel C - Participants With Mild to Moderate Hypertension | 6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days |
| BG003 | Panel D - Participants With Mild to Moderate Hypertension | 5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days |
| BG004 | Panel E - Elderly Participants With Mild/Moderate Hypertension | 6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15 |
| BG005 | Panel F - Elderly Participants With Mild/Moderate Hypertension | 6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15 |
| BG006 | Panel G - Healthy Participants | 8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria |
| BG007 | Panel H - Participants With Resistant Hypertension | In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10 |
| BG008 | Panel I - Participants With Mild to Moderate Hypertension | 12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria |
| BG009 | Panel J - Participants With Mild to Moderate Hypertension | 12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria |
| BG010 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Central Systolic Blood Pressure (cSBP) | N for Panel H = 7; N for Total = 102 | Mean | Standard Deviation | mm Hg |
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| Heart Rate (HR) | N for Panel H = 7; N for Total = 102 | Mean | Standard Deviation | beats per minute |
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| Augmentation Index (AIx) | N for Panel H = 7; N for Total = 102 | Mean | Standard Deviation | percent |
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| Central Diastolic Blood Pressure (cDBP) | N for Panel H = 7; N for Total = 102 | Mean | Standard Deviation | mm Hg |
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| Peripheral Systolic Blood Pressure (pSBP) | N for Panel H = 7; N for Total = 102 | Mean | Standard Deviation | mm Hg |
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| Peripheral Diastolic Blood Pressure (pDBP) | N for Panel H = 7; N for Total = 102 | Mean | Standard Deviation | mm Hg |
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| OG001 | Panel B - MK-8150 10 mg | MK-8150 10 mg once daily for 10 days |
| OG002 | Panel C - MK-8150 20 mg | MK-8150 20 mg once daily for 10 days |
| OG003 | Panel D - MK-8150 15 mg | MK-8150 15 mg once daily for 10 days |
| OG004 | Panel E - MK-8150 3/2 mg | Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15 |
| OG005 | Panel F - MK-8150 6/4 mg | Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15 |
| OG006 | Panel G - MK-8150 20/30/40/60 mg | MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28) |
| OG007 | Panel H - MK-8150 10/20 mg | MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10) |
| OG008 | Panel I - MK-8150 5/10/20/40 mg | MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28) |
| OG009 | Panel J - MK-8150 10/20 mg | MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28) |
| OG010 | Placebo (Panel A - J) | Combines participants who received placebo in all panels |
| OG011 | Post Study | All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug |
| OG012 | Screening | All enrolled participants, presents AEs with onset before first dose of study drug |
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| Primary | Number of Participants Discontinued From Study Drug Due to Meeting Hemodynamic Stopping Rules | Hemodynamic criteria for stopping drug dosing were applied (any of the following, obtained resting and if present for ≥1 hour, unless noted). For all Panels: HR >120 bpm; SBP ≥180 mm Hg (Panels A-D/G-J) and ≥175 mm Hg (Panels E-F); DBP ≥110 mm Hg; DBP <50 mm Hg; SBP <90 mm Hg or participant placed in Trendelenburg position. For Panels A-H: HR increase over identified baseline of ≥25 beats per minute; SBP reduction >30 mm Hg versus identified baseline; >20 mm Hg drop in SBP and >20 beats per minute rise in HR observed together versus identified baselines; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together. For Panels I-J, any of the following-down dosing criteria if still present 24 hours after dose decrease: HR increase ≥20 beats per minute versus identified baseline; SBP reduction >30 mm Hg versus identified baseline; SBP <100 mm Hg; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together. | All participants who received at least one dose of study drug | Posted | Number | participants | Up to 28 days |
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| Primary | Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | beats per minute | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | beats per minute | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | beats per minute | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs HR in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | beats per minute | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cSBP in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs HR in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | beats per minute | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | beats per minute | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | beats per minute | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM*hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose |
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| Primary | Time to Maximum Observed Plasma Concentration (Tmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Median | Full Range | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose |
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| Primary | Apparent Terminal Half-life (t1/2) of MK-8150 Determined Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 was determined. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM*hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Median | Full Range | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | t1/2 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the Day 1 dose. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 6 and Day 15 was determined. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM*hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose |
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| Primary | Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Median | Full Range | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose |
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| Primary | t1/2 of MK-8150 Determined Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 15. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | AUC0-24 of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM*hr | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Cmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | Tmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Median | Full Range | hr | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | t1/2 of MK-8150 Determined Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | AUC0-24 of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM*hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Cmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose |
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| Primary | Tmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Median | Full Range | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose |
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| Primary | t1/2 of MK-8150 Determined Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | AUC0-24 of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment) | Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined. | All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM*hr | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Cmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment) | Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | μM | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | Tmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment) | Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data. | All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure | Posted | Median | Full Range | hr | Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Primary | t1/2 of MK-8150 Determined Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment) | Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28. | All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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|
|
| Secondary | Change From Baseline in TWA0-24hrs AIx in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value (determined separately in each period). | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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|
|
| Secondary | Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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|
| Secondary | Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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|
|
| Secondary | Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period). | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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|
| Secondary | Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | percentage of pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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|
| Secondary | Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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|
| Secondary | Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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|
| Secondary | Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs AIx Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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|
| Secondary | Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mmHg | Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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| Secondary | Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J) | pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value. | All participants who met protocol entry criteria, received study drug and had data available for the measure | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose |
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|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | Panel B - MK-8150 10 mg | MK-8150 10 mg once daily for 10 days | 0 | 6 | 5 | 6 |
| EG002 | Panel C - MK-8150 20 mg | MK-8150 20 mg once daily for 10 days | 0 | 6 | 6 | 6 |
| EG003 | Panel D - MK-8150 15 mg | MK-8150 15 mg once daily for 10 days | 0 | 5 | 3 | 5 |
| EG004 | Panel E - MK-8150 3/2 mg | Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15 | 0 | 6 | 4 | 6 |
| EG005 | Panel F - MK-8150 6/4 mg | Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15 | 0 | 6 | 3 | 6 |
| EG006 | Panel G - MK-8150 20/30/40/60 mg | MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28) | 0 | 8 | 7 | 8 |
| EG007 | Panel H - MK-8150 10/20 mg | MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10) | 0 | 8 | 6 | 8 |
| EG008 | Panel I - MK-8150 5/10/20/40 mg | MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28) | 0 | 12 | 12 | 12 |
| EG009 | Panel J - MK-8150 10/20 mgEdit | MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28) | 0 | 12 | 10 | 12 |
| EG010 | Placebo (Panel A - J) | Combines participants who received placebo in all panels | 0 | 36 | 23 | 36 |
| EG011 | Post Study | All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug | 0 | 103 | 1 | 103 |
| EG012 | Screening | All enrolled participants, presents AEs with onset before first dose of study drug | 0 | 103 | 11 | 103 |
| Ear pain | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Corneal irritation | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrosis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flu-like symptoms | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Puncture site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cold | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Common cold | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal wall strained | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Skin wound | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure systolic decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Glucose increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Fasting hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cervical pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Low back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscle stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in leg | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Shoulder bursitis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness upon standing | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Intermittent headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ischialgia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Short-term memory impairment | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Microalbuminuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Throat pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis irritant contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eczematous rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Localised erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diastolic hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Systolic hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
| Day 10 (N = 5, 6, 4, 5, 8) |
|
Day 1
| Mixed Models Analysis |
| 0.005 |
| LS Mean Difference |
| -9.9 |
| Standard Error of the Mean |
| 3.2 |
| 2-Sided |
| 90 |
| -15.4 |
| -4.5 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 1 | Mixed Models Analysis | 0.000 | LS Mean Difference | -14.1 | Standard Error of the Mean | 3.3 | 2-Sided | 90 | -19.8 | -8.4 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 1 | Mixed Models Analysis | 0.030 | LS Mean Difference | -7.4 | Standard Error of the Mean | 3.2 | 2-Sided | 90 | -13.0 | -1.9 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.484 | LS Mean Difference | 3.5 | Standard Error of the Mean | 4.9 | 2-Sided | 90 | -4.9 | 11.9 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.169 | LS Mean Difference | -4.2 | Standard Error of the Mean | 3.0 | 2-Sided | 90 | -9.3 | 0.9 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.023 | LS Mean Difference | -8.7 | Standard Error of the Mean | 3.6 | 2-Sided | 90 | -14.9 | -2.6 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.605 | LS Mean Difference | -2.4 | Standard Error of the Mean | 4.6 | 2-Sided | 90 | -10.4 | 5.5 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 (N = 5, 6, 4, 5, 8) |
|
Day 1
| Mixed Models Analysis |
| 0.077 |
| LS Mean Difference |
| -5.3 |
| Standard Error of the Mean |
| 2.8 |
| 2-Sided |
| 90 |
| -10.1 |
| -0.4 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 1 | Mixed Models Analysis | 0.001 | LS Mean Difference | -10.4 | Standard Error of the Mean | 2.7 | 2-Sided | 90 | -15.0 | -5.7 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 1 | Mixed Models Analysis | 0.556 | LS Mean Difference | -2.1 | Standard Error of the Mean | 3.5 | 2-Sided | 90 | -8.0 | 3.9 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.527 | LS Mean Difference | -1.5 | Standard Error of the Mean | 2.3 | 2-Sided | 90 | -5.5 | 2.5 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.234 | LS Mean Difference | -3.4 | Standard Error of the Mean | 2.8 | 2-Sided | 90 | -8.1 | 1.4 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.002 | LS Mean Difference | -8.4 | Standard Error of the Mean | 2.5 | 2-Sided | 90 | -12.7 | -4.1 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.726 | LS Mean Difference | 1.1 | Standard Error of the Mean | 3.1 | 2-Sided | 90 | -4.2 | 6.5 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 15 (N = 5, 3) |
|
Day 6
| Mixed Models Analysis |
| 0.658 |
| LS Mean Difference |
| 3.7 |
| Standard Error of the Mean |
| 8.1 |
| 2-Sided |
| 90 |
| -10.8 |
| 18.1 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 | Mixed Models Analysis | 0.392 | LS Mean Difference | 6.3 | Standard Error of the Mean | 7.1 | 2-Sided | 90 | -6.3 | 18.9 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 15 (N = 5, 3) |
|
Day 6
| Mixed Models Analysis |
| 0.381 |
| LS Mean Difference |
| 0.8 |
| Standard Error of the Mean |
| 0.9 |
| 2-Sided |
| 90 |
| -0.8 |
| 2.5 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 | Mixed Models Analysis | 0.387 | LS Mean Difference | 1.8 | Standard Error of the Mean | 2.0 | 2-Sided | 90 | -1.7 | 5.2 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 15 (N = 4, 3) |
|
Day 6
| Mixed Models Analysis |
| 0.150 |
| LS Mean Difference |
| 7.4 |
| Standard Error of the Mean |
| 4.8 |
| 2-Sided |
| 90 |
| -1.2 |
| 15.9 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 | Mixed Models Analysis | 0.578 | LS Mean Difference | 3.0 | Standard Error of the Mean | 5.2 | 2-Sided | 90 | -6.3 | 12.3 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 15 (N = 4, 3) |
|
Day 6
| Mixed Models Analysis |
| 0.627 |
| LS Mean Difference |
| 1.9 |
| Standard Error of the Mean |
| 3.7 |
| 2-Sided |
| 90 |
| -4.8 |
| 8.5 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 | Mixed Models Analysis | 0.046 | LS Mean Difference | 4.3 | Standard Error of the Mean | 1.9 | 2-Sided | 90 | 0.9 | 7.6 | Difference is MK-8150 dose - placebo | Superiority or Other |
Day 28
| Mixed Models Analysis |
| 0.055 |
| LS Mean Difference |
| -6.0 |
| Standard Error of the Mean |
| 2.6 |
| 2-Sided |
| 90 |
| -11.0 |
| -1.1 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 (N = 7, 2) |
|
| Day 22 (N = 7, 2) |
|
| Day 28 (N = 7, 2) |
|
Day 8
| Mixed Models Analysis |
| 0.934 |
| LS Mean Difference |
| -0.3 |
| Standard Error of the Mean |
| 3.2 |
| 2-Sided |
| 90 |
| -5.7 |
| 5.2 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 | Mixed Models Analysis | 0.547 | LS Mean Difference | 2.1 | Standard Error of the Mean | 3.4 | 2-Sided | 90 | -3.7 | 7.9 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 22 | Mixed Models Analysis | 0.906 | LS Mean Difference | -0.3 | Standard Error of the Mean | 2.9 | 2-Sided | 90 | -5.2 | 4.5 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 28 | Mixed Models Analysis | 0.682 | LS Mean Difference | 1.3 | Standard Error of the Mean | 3.1 | 2-Sided | 90 | -4.0 | 6.6 | Difference is MK-8150 dose - placebo | Superiority or Other |
Day 10
| Mixed Models Analysis |
| 0.034 |
| LS Mean Difference |
| -5.9 |
| Standard Error of the Mean |
| 2.1 |
| 2-Sided |
| 90 |
| -10.1 |
| -1.7 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
Day 10
| Mixed Models Analysis |
| 0.333 |
| LS Mean Difference |
| 1.4 |
| Standard Error of the Mean |
| 1.3 |
| 2-Sided |
| 90 |
| -1.2 |
| 4.0 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
Day 28
| Mixed Models Analysis |
| 0.817 |
| LS Mean Difference |
| -0.8 |
| Standard Error of the Mean |
| 3.4 |
| 2-Sided |
| 90 |
| -6.9 |
| 5.2 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 (N = 10, 6) |
|
| Day 22 (N = 10, 6) |
|
| Day 28 (N = 10, 6) |
|
Day 8
| Mixed Models Analysis |
| 0.158 |
| LS Mean Difference |
| 3.9 |
| Standard Error of the Mean |
| 2.8 |
| 2-Sided |
| 90 |
| -0.7 |
| 8.6 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 | Mixed Models Analysis | 0.404 | LS Mean Difference | 2.4 | Standard Error of the Mean | 2.8 | 2-Sided | 90 | -2.4 | 7.1 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 22 | Mixed Models Analysis | 0.214 | LS Mean Difference | 3.0 | Standard Error of the Mean | 2.4 | 2-Sided | 90 | -1.0 | 7.1 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 28 | Mixed Models Analysis | 0.086 | LS Mean Difference | 5.1 | Standard Error of the Mean | 2.9 | 2-Sided | 90 | 0.2 | 10.0 | Difference is MK-8150 dose - placebo | Superiority or Other |
Day 28
| Mixed Models Analysis |
| 0.105 |
| LS Mean Difference |
| -6.1 |
| Standard Error of the Mean |
| 3.5 |
| 2-Sided |
| 90 |
| -12.3 |
| 0.1 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 (N = 10, 6) |
|
| Day 22 (N = 9, 6) |
|
| Day 28 (N = 9, 6) |
|
Day 8
| Mixed Models Analysis |
| 0.570 |
| LS Mean Difference |
| 2.2 |
| Standard Error of the Mean |
| 3.9 |
| 2-Sided |
| 90 |
| -4.3 |
| 8.8 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 | Mixed Models Analysis | 0.666 | LS Mean Difference | 1.5 | Standard Error of the Mean | 3.4 | 2-Sided | 90 | -4.2 | 7.1 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 22 | Mixed Models Analysis | 0.534 | LS Mean Difference | -3.0 | Standard Error of the Mean | 4.7 | 2-Sided | 90 | -10.9 | 4.9 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 28 | Mixed Models Analysis | 0.528 | LS Mean Difference | 2.5 | Standard Error of the Mean | 4.0 | 2-Sided | 90 | -4.1 | 9.2 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 (N = 5, 6, 4, 5) |
|
| Day 10 (N = 5, 6, 4, 5) |
|
| Day 10 (N = 5, 6, 4, 5) |
|
| Day 10 (N = 5, 6, 4, 5, 8) |
|
Day 1
| Mixed Models Analysis |
| <0.0001 |
| LS Mean Difference |
| -6.0 |
| Standard Error of the Mean |
| 1.2 |
| 2-Sided |
| 90 |
| -8.0 |
| -4.0 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 1 | Mixed Models Analysis | 0.025 | LS Mean Difference | -8.4 | Standard Error of the Mean | 3.5 | 2-Sided | 90 | -14.4 | -2.4 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 1 | Mixed Models Analysis | 0.044 | LS Mean Difference | -3.9 | Standard Error of the Mean | 1.8 | 2-Sided | 90 | -7.0 | -0.8 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.139 | LS Mean Difference | 3.1 | Standard Error of the Mean | 2.0 | 2-Sided | 90 | -0.4 | 6.6 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.088 | LS Mean Difference | -4.5 | Standard Error of the Mean | 2.5 | 2-Sided | 90 | -8.9 | -0.2 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.023 | LS Mean Difference | -5.5 | Standard Error of the Mean | 2.2 | 2-Sided | 90 | -9.3 | -1.6 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 10 | Mixed Models Analysis | 0.878 | LS Mean Difference | -0.4 | Standard Error of the Mean | 2.4 | 2-Sided | 90 | -4.5 | 3.8 | Difference is MK-8150 dose - placebo | Superiority or Other |
| 0.429 |
| LS Mean Difference |
| -2.4 |
| Standard Error of the Mean |
| 3.0 |
| 2-Sided |
| 90 |
| -7.5 |
| 2.7 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Mixed Models Analysis | 0.166 | LS Mean Difference | -4.2 | Standard Error of the Mean | 2.9 | 2-Sided | 90 | -9.3 | 0.8 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Mixed Models Analysis | 0.591 | LS Mean Difference | -2.1 | Standard Error of the Mean | 3.8 | 2-Sided | 90 | -8.6 | 4.5 | Difference is MK-8150 dose - placebo | Superiority or Other |
| 0.836 |
| LS Mean Difference |
| -0.6 |
| Standard Error of the Mean |
| 2.9 |
| 2-Sided |
| 90 |
| -5.6 |
| 4.4 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Mixed Models Analysis | 0.109 | LS Mean Difference | -5.3 | Standard Error of the Mean | 3.2 | 2-Sided | 90 | -10.7 | 0.1 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Mixed Models Analysis | 0.785 | LS Mean Difference | 1.0 | Standard Error of the Mean | 3.7 | 2-Sided | 90 | -5.4 | 7.5 | Difference is MK-8150 dose - placebo | Superiority or Other |
| 0.424 |
| LS Mean Difference |
| -2.4 |
| Standard Error of the Mean |
| 2.9 |
| 2-Sided |
| 90 |
| -7.4 |
| 2.6 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Mixed Models Analysis | 0.025 | LS Mean Difference | -7.8 | Standard Error of the Mean | 3.2 | 2-Sided | 90 | -13.3 | -2.2 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Mixed Models Analysis | 0.475 | LS Mean Difference | -2.2 | Standard Error of the Mean | 3.1 | 2-Sided | 90 | -7.5 | 3.0 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 15 (N = 5, 3) |
|
Day 6
| Mixed Models Analysis |
| 0.338 |
| LS Mean Difference |
| -4.3 |
| Standard Error of the Mean |
| 4.3 |
| 2-Sided |
| 90 |
| -11.9 |
| 3.4 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 | Mixed Models Analysis | 0.281 | LS Mean Difference | -3.9 | Standard Error of the Mean | 3.4 | 2-Sided | 90 | -10.0 | 2.3 | Difference is MK-8150 dose - placebo | Superiority or Other |
| Day 15 (N = 4, 3) |
|
Day 6
| Mixed Models Analysis |
| 0.090 |
| LS Mean Difference |
| -5.6 |
| Standard Error of the Mean |
| 3.0 |
| 2-Sided |
| 90 |
| -11.0 |
| -0.2 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
| Day 15 | Mixed Models Analysis | 0.028 | LS Mean Difference | -7.6 | Standard Error of the Mean | 3.0 | 2-Sided | 90 | -13.0 | -2.2 | Difference is MK-8150 dose - placebo | Superiority or Other |
Day 28
| Mixed Models Analysis |
| 0.001 |
| LS Mean Difference |
| -12.9 |
| Standard Error of the Mean |
| 2.3 |
| 2-Sided |
| 90 |
| -17.2 |
| -8.6 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
Day 10
| Mixed Models Analysis |
| 0.001 |
| LS Mean Difference |
| -8.2 |
| Standard Error of the Mean |
| 1.2 |
| 2-Sided |
| 90 |
| -10.7 |
| -5.7 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
Day 28
| Mixed Models Analysis |
| 0.063 |
| LS Mean Difference |
| -5.8 |
| Standard Error of the Mean |
| 2.9 |
| 2-Sided |
| 90 |
| -10.8 |
| -0.7 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |
Day 28
| Mixed Models Analysis |
| 0.161 |
| LS Mean Difference |
| -3.8 |
| Standard Error of the Mean |
| 2.6 |
| 2-Sided |
| 90 |
| -8.3 |
| 0.7 |
Difference is MK-8150 dose - placebo |
| Superiority or Other |