A Study to Investigate the Antihypertensive Efficacy of MK0954

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: losartan potassium

• Registration Number: NCT00887250
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1991-12
• Primary Completion: 1992-08
• Study Completion: 1992-11
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• 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: 2009-07-08
• Last Update Posted: 2009-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	losartan potassium	Losartan 50 mg for 12 weeks

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 post dose)	Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12

Secondary Outcome Measures

Name	Time	Method
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6	24 hours post dose 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.
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12	24 hours post dose 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.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6	At baseline and at 6 weeks (24 hours post dose)	Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6	At baseline and at 6 weeks (24 hours post dose)	Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12	At baseline and at 12 weeks (6 hours post dose)	Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12