A Double-blind, Randomized, Parallel-group, Placebo-controlled Pilot Study to Investigate the Magnitude and Duration of Response and the Safety of MK0954 (50 mg Given Once or Twice Daily, or 100 mg Given Once Daily) Compared to Placebo Using Ambulatory Blood Pressure Monitoring
Overview
- Phase
- Phase 3
- Intervention
- hydrochlorothiazide (HCTZ)
- Conditions
- Hypertension
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 122
- Primary Endpoint
- Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Non-black men and women with mild to moderate hypertension and within 30% of their ideal body weight
- •Patient is in good general health
- •Blood pressure at time of randomization is 95-115 mm Hg
Exclusion Criteria
- •Secondary Hypertension or history of malignant hypertension
- •History of stroke
- •History of myocardial infarction
- •Atrial flutter or atrial fibrillation
- •History of congestive Heart failure
- •Patient taking major psychotropic agent or anti-depressant
- •Patient regularly uses NSAIDS or high dose aspirin
- •Known positive test for HIV/AIDS or Hepatitis B
- •Patient is being treated for acute ulcer disease
- •Prior exposure to losartan
Arms & Interventions
3
losartan 100 mg q.d.
Intervention: hydrochlorothiazide (HCTZ)
1
Placebo
Intervention: hydrochlorothiazide (HCTZ)
2
losartan 50 mg q.d.
Intervention: losartan potassium
2
losartan 50 mg q.d.
Intervention: hydrochlorothiazide (HCTZ)
3
losartan 100 mg q.d.
Intervention: losartan potassium
4
losartan 50 mg b.i.d.
Intervention: losartan potassium
4
losartan 50 mg b.i.d.
Intervention: hydrochlorothiazide (HCTZ)
Outcomes
Primary Outcomes
Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
Time Frame: 24 hour period at Baseline and Week 4
Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
Time Frame: 24-hour period at baseline and Week 4
Secondary Outcomes
- Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6(Baseline and 24-hours after morning dose at Week 6)
- Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4(Baseline and 24-hours after morning dose at Week 4)
- Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6(Baseline and 24-hours after morning dose at Week 6)