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| ID | Type | Description | Link |
|---|---|---|---|
| MK0954-050 |
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After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. This study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | Losartan 50 mg for 12 weeks |
|
| 3 | Experimental | Losartan 50 mg titrated to 100 mg after 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| losartan potassium | Drug | 50 mg Losartan (MK0954) tablet taken once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12 | At baseline and at 12 weeks (24 hours post dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 | Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III. | 24 hours post dose at Week 6 |
| Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 |
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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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Patients could be randomized after the 4-week placebo baseline period if their mean sitting diastolic blood pressure (SiDBP) was 95-115 mm Hg and ≤7 mm Hg from the mean SiDBP after 2 weeks of placebo therapy
Patients were recruited at 22 sites in the United States. Prime Therapy Period: December, 1991 to August, 1992.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Losartan placebo orally once daily for 12 weeks |
| FG001 | Losartan 50 mg | Losartan 50 mg orally once daily for 12 weeks |
| FG002 | Losartan 50/100 mg | Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Losartan placebo orally once daily for 12 weeks |
| BG001 | Losartan 50 mg | Losartan 50 mg orally once daily for 12 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12 | 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 | At baseline and at 12 weeks (24 hours post dose) |
|
Safety has been reported in the literature.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck & Co., Inc. | 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 |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Comparator: losartan | Drug | 50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks. |
|
|
| Comparator: Placebo | Drug | Placebo to Losartan |
|
Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III. |
| 24 hours post dose at Week 12 |
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6 | Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6 | At baseline and at 6 weeks (24 hours post dose) |
| Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6 | Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6 | At baseline and at 6 weeks (24 hours post dose) |
| Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12 | At baseline and at 12 weeks (6 hours post dose) |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient uncooperative |
|
| BG002 | Losartan 50/100 mg | Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Sitting Diastolic Blood Pressure (SiDBP) | Mean | Full Range | mm Hg |
|
Losartan 50 mg orally once daily for 12 weeks |
| OG002 | Losartan 50/100 mg | Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks |
|
|
| Secondary | Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 | Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III. | 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 6 |
|
|
|
| Secondary | Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 | Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III. | 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 12 |
|
|
|
| Secondary | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6 | Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6 | 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 | At baseline and at 6 weeks (24 hours post dose) |
|
|
|
| Secondary | Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6 | Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6 | 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 | At baseline and at 6 weeks (24 hours post dose) |
|
|
|
| Secondary | Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12 | 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 | At baseline and at 12 weeks (6 hours post dose) |
|
|
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| Title | Measurements |
|---|---|
|
| Category III |
|
| Title | Measurements |
|---|---|
|
| Category III |
|