A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)
Phase 3
Completed
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00882440
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 576
Inclusion Criteria
- Patient has been diagnosed with mild to moderate hypertension, with supine diastolic blood pressure of 100 to 115 mmHg
- Patient has no active medical problems other than essential hypertension that might affect blood pressure
- Patient has received no drug therapy that might affect blood pressure
Exclusion Criteria
- Prior exposure to losartan
- History of stroke
- History of myocardial infarction
- Atrial flutter or atrial fibrillation
- History of congestive Heart failure
- Known Sensitivity to ACE inhibitors
- Known positive test for HIV/AIDS or Hepatitis B
- Patient is being treated for acute ulcer disease
- History of chronic liver disease
- Actively treated diabetes mellitis
- Any known bleeding or platelet disorder
- Absence of one kidney
- Women of childbearing potential or who are breastfeeding
- Patient is abusing or has a history of alcoholism or drug addiction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 losartan potassium Losartan 50 mg 5 losartan potassium Losartan 100 mg 6 losartan potassium Losartan 150 mg 7 Enalapril Enalapril 20 mg 1 Placebo Placebo 2 losartan potassium Losartan 10 mg 3 losartan potassium Losartan 25 mg
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 24 hours post dose at Baseline and Week 8
- Secondary Outcome Measures
Name Time Method Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 24 hours post dose 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.
Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8 6 hours post dose at Baseline and 8 weeks