MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

Study Overview
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Brief Summary
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The study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. Patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of Losartan.

Official Title
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A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Losartan Given Once or Twice Daily in Patients With Mild to Moderate Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: losartan potassium
* 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 Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure Exclusion Criteria: Pregnant of lactating female patients Secondary hypertension or history of malignant hypertension Sitting systolic blood pressure > 210 mmHg History of stroke History of myocardial infarction with in the past year Current of prior history of heart failure Known hypersensitivity to losartan Obesity Patients known to be HIV positive or known to be positive for Hepatitis B Absence of one kidney Patient is abusing or previously abused alcohol or drugs with in past two 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 tablet q.a.m. , for 12 weeks<br>|
| Experimental: 2<br>Losartan 50 q.a.m. | Drug: losartan potassium<br>* losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks<br>* Other names: MK0954;|
| Experimental: 3<br>Losartan 25 b.i.d. | Drug: losartan potassium<br>* losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks<br>* Other names: MK0954;|
| Experimental: 4<br>Losartan 25 q.a.m. | Drug: losartan potassium<br>* losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 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 after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) | 
| Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12 | At baseline and at 12 weeks (6 hours after last morning dose) | 
| Categories of Antihypertensive Response in Trough Sitting 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 or increased were in Category III. | 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks |