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| ID | Type | Description | Link |
|---|---|---|---|
| MK0954-011 | |||
| 2009_574 |
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The purpose of this study was to compare the antihypertensive efficacy of different doses of losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure of 100-115 mmHg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | Losartan 10 mg |
|
| 3 | Experimental | Losartan 25 mg |
|
| 4 | Experimental | Losartan 50 mg |
|
| 5 | Experimental | Losartan 100 mg |
|
| 6 | Experimental | Losartan 150 mg |
|
| 7 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| losartan potassium | Drug | losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 | 24 hours post dose at Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 | Patients in Category I (defined as "excellent" in protocol) if SuDBP was <90 mmHg, Category II (defined as "good" in protocol) if SuDBP was ≥90 but decreased at least 10 mmHg, or Category III (defined as "fair" or "inadequate" in protocol) if SuDBP was ≥90 and decreased less than 10 mmHg. | 24 hours post dose at Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7768585 | Background | Gradman AH, Arcuri KE, Goldberg AI, Ikeda LS, Nelson EB, Snavely DB, Sweet CS. A randomized, placebo-controlled, double-blind, parallel study of various doses of losartan potassium compared with enalapril maleate in patients with essential hypertension. Hypertension. 1995 Jun;25(6):1345-50. doi: 10.1161/01.hyp.25.6.1345. |
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Patients could be randomized after the 4-week placebo baseline period if their mean supine diastolic blood pressure (SuDBP) was 100-115 mmHg and ≤7 mmHg from the mean SuDBP after 2 weeks of placebo therapy, or after a 2-week placebo baseline period if 2 sets of SuDBP data were within 100-115 mmHg, ≥3 days apart and differed by ≤7 mmHg.
Patients were recruited at 28 sites in the United States. Primary Therapy Period: December, 1990-August, 1991
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Losartan and Enalapril placebo orally once daily for 8 weeks |
| FG001 | Losartan 10 mg | Losartan 10 mg orally once daily for 8 weeks |
| FG002 | Losartan 25 mg | Losartan 25 mg orally once daily for 8 weeks |
| FG003 | Losartan 50 mg | Losartan 50 mg orally once daily for 8 weeks |
| FG004 | Losartan 100 mg | Losartan 100 mg orally once daily for 8 weeks |
| FG005 | Losartan 150 mg | Losartan 150 mg orally once daily for 8 weeks |
| FG006 | Enalapril 20 | Enalapril 20 mg orally once daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Losartan and Enalapril placebo orally once daily for 8 weeks |
| BG001 | Losartan 10 mg | Losartan 10 mg orally once daily for 8 weeks |
| 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 | Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 | Patients in Category I (defined as "excellent" in protocol) if SuDBP was <90 mmHg, Category II (defined as "good" in protocol) if SuDBP was ≥90 but decreased at least 10 mmHg, or Category III (defined as "fair" or "inadequate" in protocol) if SuDBP was ≥90 and decreased less than 10 mmHg. | An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | Posted | Number | Participants | 24 hours post dose at Week 8 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D004656 | Enalapril |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Enalapril 20 mg |
|
|
| Placebo | Drug | Placebo capsule to losartan |
|
| Enalapril | Drug | Enalapril 20 mg oral tablet taken once daily for 8 weeks |
|
| Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8 | 6 hours post dose at Baseline and 8 weeks |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient Uncooperative |
|
| BG002 | Losartan 25 mg | Losartan 25 mg orally once daily for 8 weeks |
| BG003 | Losartan 50 mg | Losartan 50 mg orally once daily for 8 weeks |
| BG004 | Losartan 100 mg | Losartan 100 mg orally once daily for 8 weeks |
| BG005 | Losartan 150 mg | Losartan 150 mg orally once daily for 8 weeks |
| BG006 | Enalapril 20 | Enalapril 20 mg orally once daily for 8 weeks |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity | Number | participants |
|
| SuDBP | Supine Diastolic Blood Pressure (SuDBP) | Mean | Standard Deviation | mmHg |
|
| OG001 | Losartan 10 mg | Losartan 10 mg orally once daily for 8 weeks |
| OG002 | Losartan 25 mg | Losartan 25 mg orally once daily for 8 weeks |
| OG003 | Losartan 50 mg | Losartan 50 mg orally once daily for 8 weeks |
| OG004 | Losartan 100 mg | Losartan 100 mg orally once daily for 8 weeks |
| OG005 | Losartan 150 mg | Losartan 150 mg orally once daily for 8 weeks |
| OG006 | Enalapril 20 | Enalapril 20 mg orally once daily for 8 weeks |
|
|
| Primary | Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 | The primary analysis employed an "all patients treated" approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | Posted | Mean | Standard Deviation | mm Hg | 24 hours post dose at Baseline and Week 8 |
|
|
|
| Secondary | Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8 | An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | Posted | Mean | Standard Deviation | mm Hg | 6 hours post dose at Baseline and 8 weeks |
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Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |