A Study to Investigate the Antihypertensive Efficacy of MK0954

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan (MK954, DuP753) in Patients With Mild to

Conditions
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Hypertension

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


Participation Criteria
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Eligibility Criteria
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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

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 to Losartan<br>|
| Experimental: 2<br>Losartan 50 mg for 12 weeks | Drug: losartan potassium<br>* 50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.<br>* Other names: MK0954;|
| Experimental: 3<br>Losartan 50 mg titrated to 100 mg after 6 weeks | Drug: Comparator: losartan<br>* 50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.<br>* Other names: MK0954;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12 | At baseline and at 12 weeks (24 hours post dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 | Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III. | 24 hours post dose at Week 6 | 
| Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 | Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III. | 24 hours post dose at Week 12 | 
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6 | Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6 | At baseline and at 6 weeks (24 hours post dose) | 
| Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6 | Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6 | At baseline and at 6 weeks (24 hours post dose) | 
| Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12 | At baseline and at 12 weeks (6 hours post dose) |