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This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-954H (L50/H12.5) | Active Comparator | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension) |
|
| MK-0954A (L100/H12.5) | Experimental | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0954A | Drug | Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension) | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8 | Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings. |
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Inclusion criteria:
Exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24990091 | Result | Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Fujimoto G, Azuma K, Shirakawa M, Hanson ME, Fujita KP. Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials. Hypertens Res. 2014 Dec;37(12):1042-9. doi: 10.1038/hr.2014.114. Epub 2014 Jul 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-0954H (L50/H12.5) Double Blind Period (Period 1) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5) |
| FG001 | MK-0954A (L100/H12.5) Double Blind Period (Period 1) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5) |
| FG002 | L50/H12.5→L100/H12.5 Open Label (Period 2) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension) |
| FG003 | L100/H12.5→L100/H12.5 Open Label (Period 2) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8-week Double-blind Period |
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| ||||||||||||||||||
| 44-week Open-label Extension |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-0954H (L50/H12.5) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension) |
| BG001 | MK-0954A (L100/H12.5) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8 | Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings. | Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Week 8 (End of Double-blind Period) |
|
52 weeks
All-Patients-as-Treated (APaT) Population defined as all randomized participants who received at least one dose of study treatment.
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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 | MK-0954H (L50/H12.5) Double Blind Period (Period 1) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess neck | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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 |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C505809 | hydrochlorothiazide, losartan drug combination |
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| MK-954H | Drug | Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily |
|
|
| Placebo to MK-0954A | Drug | Placebo tablet to match MK-0954A, once daily |
|
| Placebo to MK-954H | Drug | Placebo tablet to match MK-954H, once daily |
|
| Baseline and Week 8 (End of Double-blind Period) |
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 | Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings. | Baseline and Week 8 (End of Double-blind Period) |
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Blood Pressure Withdrawal Criteria Met |
|
| Potassium Withdrawal Criteria Met |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5).
| OG001 | MK-0954A (L100/H12.5) | One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). |
|
|
|
| Secondary | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 | Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings. | Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline and Week 8 (End of Double-blind Period) |
|
|
|
|
| Primary | Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension) | All-Patients-as-Treated (APaT) Population, which consists of all randomized patients who received at least one dose of MK-0954A. The L100/H12.5 (L50/H12.5) arm only includes data from extension period (44 weeks); L100/H12.5→L100/H12.5 Open Label arm includes data from entire study period (52 weeks). | Posted | Number | Percentage of Participants | Up to 52 weeks |
|
|
|
| 1 |
| 144 |
| 18 |
| 144 |
| EG001 | MK-0954A (L100/H12.5) Double Blind Period (Period 1) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5) | 2 | 134 | 20 | 134 |
| EG002 | L50/H12.5→L100/H12.5 Open Label (Period 2) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension) | 6 | 131 | 47 | 131 |
| EG003 | L100/H12.5→L100/H12.5 Open Label (Period 2) | One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension | 1 | 127 | 43 | 127 |
| Limb crushing injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Spinal column stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Blood uric acid increased | Investigations | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | 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.