A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Different Doses of DuP 753 (MK0954)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: losartan potassium
* Drug: Placebo
* Drug: Enalapril


Participation Criteria
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Eligibility Criteria
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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

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: Placebo<br>* Placebo capsule to losartan<br>|
| Experimental: 2<br>Losartan 10 mg | Drug: losartan potassium<br>* losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks<br>* Other names: Cozaar;|
| Experimental: 3<br>Losartan 25 mg | Drug: losartan potassium<br>* losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks<br>* Other names: Cozaar;|
| Experimental: 4<br>Losartan 50 mg | Drug: losartan potassium<br>* losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks<br>* Other names: Cozaar;|
| Experimental: 5<br>Losartan 100 mg | Drug: losartan potassium<br>* losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks<br>* Other names: Cozaar;|
| Experimental: 6<br>Losartan 150 mg | Drug: losartan potassium<br>* losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks<br>* Other names: Cozaar;|
| Active Comparator: 7<br>Enalapril 20 mg | Drug: Enalapril<br>* Enalapril 20 mg oral tablet taken once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) 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. | 24 hours post dose at Week 8 | 
| Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8 |  | 6 hours post dose at Baseline and 8 weeks |