MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: losartan potassium

• Registration Number: NCT00888355
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1992-05
• Primary Completion: 1993-01
• Study Completion: 1993-02
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Results First Submitted: 2009-05-07
• Results First Submitted QC: 2009-05-07
• Results First Posted: 2009-06-24
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-02
• Last Update Posted: 2009-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	losartan potassium	Losartan 25 b.i.d.
4	losartan potassium	Losartan 25 q.a.m.
2	losartan potassium	Losartan 50 q.a.m.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) 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 trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as 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 trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12	At baseline and at 12 weeks (6 hours after last morning dose)	Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12
Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12	24 hours after last morning dose and 12 hours after last PM dose at 12 weeks	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.