Phase 3
Completed N=366
A Study to Investigate the Antihypertensive Efficacy of MK0954
Source: ClinicalTrials.gov NCT00887250 ↗Enrolled (actual)
366
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 — -4.3; -7.9; -8.6 mm Hg
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 |
-4.3; -7.9; -8.6 | — |
| SECONDARY Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 |
14; 37; 37; 8; 20; 21 | — |
| SECONDARY Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 |
19; 40; 37; 12; 18; 24 | — |
| SECONDARY Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6 |
-3.5; -6.9; -7.9 | — |
| SECONDARY Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6 |
-4.1; -9.7; -8.9 | — |
| SECONDARY Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 |
-4.7; -9.5; -10.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)
- Patient has no medical problems or treatments that might effect their blood pressure
Exclusion Criteria
- Pregnant or lactating females
- Patient has secondary hypertension or malignant hypertension
- Sitting systolic blood pressure > 210 mm Hg
- History of stroke
- History of myocardial infarction with in past year
- Current or prior history of heart failure
- Known hypersensitivity to losartan
- Prior exposure to losartan
- Patients known to be HIV positive
- Patient is abusing or has abused alcohol or other drugs within the past 4 years
Data sourced from ClinicalTrials.gov (NCT00887250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.