A Study to Investigate the Antihypertensive Efficacy of MK0954

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Comparator: Placebo; Drug: losartan potassium; Drug: Comparator: losartan

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Placebo	Drug: Comparator: Placebo; Placebo to Losartan
Experimental: 2; Losartan 50 mg for 12 weeks	Drug: losartan potassium; 50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.; Other Names: MK0954
Experimental: 3; Losartan 50 mg titrated to 100 mg after 6 weeks	Drug: Comparator: losartan; 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.; Other Names: MK0954

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: December 1, 1991
• Primary Completion (Actual): August 1, 1992
• Study Completion (Actual): November 1, 1992

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Estimate): July 14, 2009
• Last Update Submitted That Met QC Criteria: July 8, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: 2009_580; MK0954-050