A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: losartan potassium
* Drug: Comparator: placebo
* Drug: hydrochlorothiazide (HCTZ)


Participation Criteria
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Eligibility Criteria
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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 Actively treated diabetes mellitus History of chronic liver disease Actively treated diabetes mellitus Any known bleeding or platelet disorder Absence of one kidney Women of childbearing potential Alcoholism or drug addiction

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Comparator: placebo<br>* placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks<br>Drug: hydrochlorothiazide (HCTZ)<br>* open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks<br>* Other names: HCTZ;|
| Experimental: 2<br>losartan 50 mg q.d. | Drug: losartan potassium<br>* losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks<br>* Other names: MK0954;Drug: hydrochlorothiazide (HCTZ)<br>* open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks<br>* Other names: HCTZ;|
| Experimental: 3<br>losartan 100 mg q.d. | Drug: losartan potassium<br>* losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks<br>* Other names: MK0954;Drug: hydrochlorothiazide (HCTZ)<br>* open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks<br>* Other names: HCTZ;|
| Experimental: 4<br>losartan 50 mg b.i.d. | Drug: losartan potassium<br>* losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks<br>* Other names: MK0954;Drug: hydrochlorothiazide (HCTZ)<br>* open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks<br>* Other names: HCTZ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 |  | 24 hour period at Baseline and Week 4 | 
| Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 |  | 24-hour period at baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |