A Study of MK-7145 Compared to Placebo and Hydrochlorothi... | NCT01370655

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MK-7145 6 mg (Treatment A)	Experimental	MK-7145 3 mg (three x 1-mg MK-7145 capsules administered orally) and placebo to HCTZ (two 12.5-mg capsules) then three x 1-mg MK-7145 capsules 4 hours later, daily for 4 weeks.	Drug: MK-7145 Drug: Placebo to HCTZ
MK-7145 3 mg (Treatment B)	Experimental	MK-7145 3 mg (one 2mg MK-7145 and one MK-7145 placebo capsule) then one 1-mg MK-7145 capsule and two MK-7145 placebo capsules 4 hours later and placebo to HCTZ (2 capsules once daily) daily for 4 weeks.	Drug: MK-7145 Drug: Placebo to MK-7145 Drug: Placebo to HCTZ
Hydrochlorothiazide 25 mg (Treatment C)	Active Comparator	HCTZ 25 mg (two 12.5-mg capsules) and placebo to MK-7145 (one 3-mg capsule) then placebo for MK-7145 (one 3-mg capsule) 4 hours later daily for 4 weeks.	Drug: Hydrochlorothiazide (HCTZ) Drug: Placebo to MK-7145
Placebo (Treatment D)	Placebo Comparator	Placebo to MK-7145 (2 x 3-mg capsules) and placebo to HCTZ 25 mg (2 capsules) then placebo to MK-7145 (2 x 3-mg capsules) 4 hours later daily for 4 weeks	Drug: Placebo to MK-7145 Drug: Placebo to HCTZ

Name	Type	Description	Arm Group Labels	Other Names
MK-7145	Drug		MK-7145 3 mg (Treatment B) MK-7145 6 mg (Treatment A)
Hydrochlorothiazide (HCTZ)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)	Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.	Baseline and Day 28
Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)	Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average diastolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.	Baseline and Day 28
Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1	Urine sodium (Na) levels were measured over 24-hours on Day -1 (baseline) and on Day 1. The total amount of Na excreted in the urine for Day-1 (baseline) and Day1 were calculated and the difference between the 2 values was recorded.	Baseline (Day-1) and Day 1
Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)	An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE during the study was summarized by study drug taken at the time of the AE.	Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Urine Potassium at 24 Hours Post-dose on Day 28	Urine potassium (K+) levels were measured over 24-hours on Day -1 and on Day 28. The total amount of K+ excreted in the urine for Day-1 (baseline) and Day 28 were calculated and the difference between the 2 values was recorded.	Baseline (Day -1) and Day 28

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Diagnosis of essential hypertension
Body mass index (BMI) ≤35 kg/m^2
Participant in general good health
No history of clinically significant arrhythmias or clinically significant abnormality on electrocardiogram (ECG)
No history of clinically significant cardiac disease
Treatment-naïve or taking up to 2 antihypertensive therapeutic agents
Non-smoker and/or has not used nicotine or nicotine-containing products for at least 6 months

Exclusion criteria:

Participant has low plasma potassium
History of stroke, chronic seizures, or major neurological disorder
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of osteoporosis
Active or history of nephrocalcinosis, nephrolithiasis or hypercalciuria
Orthostatic change in vital sign measurements while going from a semi-recumbent to standing position accompanied by symptoms
Functional disability that can interfere with rising from a semi-recumbent position to the standing position
History of malignant neoplastic disease. Exceptions: (1) adequately treated non-melanomatous skin carcinoma; (2) other malignancies which have been successfully treated >10 years prior to the prestudy (screening) visit, (3) unlikely to sustain a recurrence
Participant is unable to refrain from the use of prescription and non-prescription drugs such as high-dose aspirin (≥325 mg/day), strong/moderate Cytochrome P450 3A4 (CYP3A4) inhibitors (such as ritonavir, indinavir, nelfinavir, erythromycin, telithromycin, clarithromycin, chloramphenicol, fluconazole, ketoconazole, itraconazole, nefazodone, aprepitant, verapamil, or diltiazem) as well as strong/moderate CYP3A4 inducers (such as phenytoin, carbamazepine, oxcarbazepine, phenobarbital, efavirenz, nevirapine, etravirine, rifampicin, modafinil, St Johns Wort, cyproterone, or progestin) beginning approximately 2 weeks (or 5 half-lives), prior to administration of the initial dose of study drug until the post study visit
Current use of non-steroidal anti-inflammatory drugs (NSAIDs) other than low dose aspirin, aluminum- or magnesium-containing antacids, sucralfate, metal cations such as iron, multivitamins containing iron or zinc that cannot be discontinued at least 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug until the post study visit
Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
Participant consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
Major surgery, donation or lost 1 unit of blood (approximately 500 mL), or participation in another investigational study within 4 weeks prior to the prestudy (screening)
History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Regular use of any illicit drugs or history of drug abuse within approximately 6 months
Dehydration or volume-depletion

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

ID	Title	Description
FG000	Treatment A → Treatment C	Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
FG001	Treatment C → Treatment A

Arm/Group Information

ID	Title	Description
BG000	Treatment A → Treatment C	Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
BG001	Treatment C → Treatment A	Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
BG002	Treatment A → Treatment D	Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
BG003	Treatment D → Treatment A	Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
BG004	Treament D → Treatment C	Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
BG005	Treatment C → Treatment D	Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
BG006	Treatment A → Treatment B	Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
BG007	Treatment B → Treatment A	Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
BG008	Treatment B → Treatment C	Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
BG009	Treatment C → Treatment B	Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
BG010	Treatment B → Treatment D	Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
BG011	Treatment D → Treament B	Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
BG012	Total	Total of all reporting groups

Units	Counts
Participants	BG0007 BG0017 BG0023 BG0033 BG0043 BG0054 BG0064 BG0074 BG0083 BG0092 BG0103 BG0113 BG01246

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

Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)

Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.

All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.

Posted

Least Squares Mean

90% Confidence Interval

mmHg

Baseline and Day 28

ID	Title	Description
OG000	MK-7145 3 mg	Participants received 3 mg MK-7145 daily for 4 weeks
OG001	MK-7145 6 mg	Participants received 6 mg MK-7145 for 4 weeks
OG002	HCTZ 25 mg	Participants received HCTZ 25 mg daily for 4 weeks
OG003	Placebo	Participants received Placebo MK-7145 daily for 4 weeks

Units	Counts
Participants	OG00017 OG00125 OG00221 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-9.5(-12.7 to -6.4) OG001-10.2(-12.8 to -7.6) OG002-4.8(-7.6 to -1.9) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001 OG003	Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.					Difference in Least square (LS) means	-7.4			2-Sided	80	-10.6	-4.1			MK-7145 6 mg LS mean minus Placebo LS mean		Non-Inferiority or Equivalence	Hypothesis supported if the upper bound of the two-sided 80% confidence interval (CI; equivalent to a one-sided upper 90% CI) is ≤0 mmHg

Primary

Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)

Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average diastolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.

Posted

Least Squares Mean

90% Confidence Interval

mmHg

Baseline and Day 28

ID	Title	Description
OG000	MK-7145 3 mg	Participants received 3 mg MK-7145 daily for 4 weeks
OG001	MK-7145 6 mg	Participants received 6 mg MK-7145 for 4 weeks
OG002	HCTZ 25 mg	Participants received HCTZ 25 mg daily for 4 weeks
OG003	Placebo

Primary

Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1

Urine sodium (Na) levels were measured over 24-hours on Day -1 (baseline) and on Day 1. The total amount of Na excreted in the urine for Day-1 (baseline) and Day1 were calculated and the difference between the 2 values was recorded.

Posted

Least Squares Mean

90% Confidence Interval

mmol/day

Baseline (Day-1) and Day 1

ID	Title	Description
OG000	MK-7145 3 mg	Participants received 3 mg MK-7145 daily for 4 weeks
OG001	MK-7145 6 mg	Participants received 6 mg MK-7145 for 4 weeks
OG002	HCTZ 25 mg	Participants received HCTZ 25 mg daily for 4 weeks
OG003	Placebo	Participants received Placebo MK-7145 daily for 4 weeks

Primary

Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE during the study was summarized by study drug taken at the time of the AE.

All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.

Posted

Number

Percentage of Participants

Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)

ID	Title	Description
OG000	MK-7145 3 mg	Participants received 3 mg MK-7145 daily for 4 weeks
OG001	MK-7145 6 mg	Participants received 6 mg MK-7145 for 4 weeks
OG002	HCTZ 25 mg	Participants received HCTZ 25 mg daily for 4 weeks

Primary

Percentage of Participants Who Had Study Discontinued During the Study Due to an Adverse Event (AE)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had the administration of the study drug discontinued during the study was summarized by study drug taken at the time of the AE. Participants may or may not have completed the study.

All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.

Posted

Number

Percentage of Participants

up to 4 weeks of each treatment period

ID	Title	Description
OG000	MK-7145 3 mg	Participants received 3 mg MK-7145 daily for 4 weeks
OG001	MK-7145 6 mg	Participants received 6 mg MK-7145 for 4 weeks
OG002	HCTZ 25 mg	Participants received HCTZ 25 mg daily for 4 weeks

Primary

Percentage of Participants Who Experienced at Least 1 Drug-related Adverse Event (AE)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE that was reported as at least possibly-related to the study was summarized by study drug taken at the time of the AE.

All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.

Posted

Number

Percentage of Participants

Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)

ID	Title	Description
OG000	MK-7145 3 mg	Participants received 3 mg MK-7145 daily for 4 weeks
OG001	MK-7145 6 mg	Participants received 6 mg MK-7145 for 4 weeks
OG002	HCTZ 25 mg	Participants received HCTZ 25 mg daily for 4 weeks

Secondary

Change From Baseline in Urine Potassium at 24 Hours Post-dose on Day 28

Urine potassium (K+) levels were measured over 24-hours on Day -1 and on Day 28. The total amount of K+ excreted in the urine for Day-1 (baseline) and Day 28 were calculated and the difference between the 2 values was recorded.

Posted

Least Squares Mean

90% Confidence Interval

mmol/day

Baseline (Day -1) and Day 28

ID	Title	Description
OG000	MK-7145 3 mg	Participants received 3 mg MK-7145 daily for 4 weeks
OG001	MK-7145 6 mg	Participants received 6 mg MK-7145 for 4 weeks
OG002	HCTZ 25 mg	Participants received HCTZ 25 mg daily for 4 weeks
OG003	Placebo	Participants received Placebo MK-7145 daily for 4 weeks

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG0030 events0 affected19 at risk
Eye pain	Eye disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG003
Vision blurred	Eye disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0012 events2 affected28 at risk EG0020 events0 affected26 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0011 events1 affected28 at risk EG0020 events0 affected26 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0019 events5 affected28 at risk EG0023 events3 affected26 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0013 events3 affected28 at risk EG0020 events0 affected26 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected28 at risk EG0020 events0 affected26 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 14.1	Systematic Assessment	EG0002 events2 affected19 at risk EG0013 events2 affected28 at risk EG0020 events0 affected26 at risk EG003
Fatigue	General disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0021 events1 affected26 at risk EG003
Thirst	General disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0013 events3 affected28 at risk EG0020 events0 affected26 at risk EG003
Bronchitis	Infections and infestations	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0016 events6 affected28 at risk EG0025 events5 affected26 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG003
Blood aldosterone increased	Investigations	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0021 events1 affected26 at risk EG003
Blood potassium decreased	Investigations	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected28 at risk EG0020 events0 affected26 at risk EG003
Blood pressure systolic increased	Investigations	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG003
Blood uric acid increased	Investigations	MedDRA version 14.1	Systematic Assessment	EG0008 events2 affected19 at risk EG00115 events4 affected28 at risk EG0021 events1 affected26 at risk EG003
Weight decreased	Investigations	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected28 at risk EG0020 events0 affected26 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected28 at risk EG0021 events1 affected26 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0015 events2 affected28 at risk EG0022 events1 affected26 at risk EG003
Headache	Nervous system disorders	MedDRA version 14.1	Systematic Assessment	EG0008 events5 affected19 at risk EG00110 events8 affected28 at risk EG00213 events6 affected26 at risk EG003
Presyncope	Nervous system disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected28 at risk EG0021 events1 affected26 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA version 14.1	Systematic Assessment	EG0002 events2 affected19 at risk EG0012 events2 affected28 at risk EG0022 events2 affected26 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected28 at risk EG0020 events0 affected26 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG003
Nocturnal dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0011 events1 affected28 at risk EG0020 events0 affected26 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA version 14.1	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected28 at risk EG0020 events0 affected26 at risk EG003

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D002740	Chlorothiazide
D001581	Benzothiadiazines
D013449	Sulfonamides
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D049971	Thiazides
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MK-7145 3 mg	Participants received 3 mg MK-7145 daily for 4 weeks	0	19	16	19
EG001	MK-7145 6 mg	Participants received 6 mg MK-7145 for 4 weeks	1	28	19	28
EG002	HCTZ 25 mg	Participants received HCTZ 25 mg daily for 4 weeks	2	26	15	26
EG003	Placebo	Participants received Placebo MK-7145 daily for 4 weeks	0	19	9	19

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected28 at risk EG0020 events0 affected26 at risk EG0030 events0 affected19 at risk
Migraine	Nervous system disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0010 events0 affected28 at risk EG0021 events1 affected26 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 14.1	Systematic Assessment	EG0000 events0 affected19 at risk EG0010 events0 affected28 at risk EG0021 events1 affected26 at risk EG003