MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 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
• 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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Placebo	Drug: Comparator: placebo; placebo to losartan tablet q.a.m. , for 12 weeks
Experimental: 2; Losartan 50 q.a.m.	Drug: losartan potassium; losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks; Other Names: MK0954
Experimental: 3; Losartan 25 b.i.d.	Drug: losartan potassium; losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks; Other Names: MK0954
Experimental: 4; Losartan 25 q.a.m.	Drug: losartan potassium; losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Clinical Adverse Experiences (CAEs)	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	12 weeks
Number of Patients With Serious CAEs	Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	12 weeks
Number of Patients With Drug-related CAEs	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period	12 weeks
Number of Patients Discontinued Due to CAEs	Patients discontinued due to CAEs during the 12-week treatment period	12 weeks
Number of Patients Who Died	Patients who died during the 12-week treatment period	12 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs)	A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product	12 weeks
Number of Patients With Serious LAEs	Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	12 weeks
Number of Patients With Drug-related LAEs	Patients with drug-related LAEs during the 12-week treatment period	12 weeks
Number of Patients Discontinued Due to LAEs	Patients discontinued due to LAEs during the 12-week treatment period	12 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: May 1, 1992
• Primary Completion (Actual): January 1, 1993
• Study Completion (Actual): February 1, 1993

Study Registration Dates

• First Submitted: April 24, 2009
• First Submitted That Met QC Criteria: April 24, 2009
• First Posted (Estimate): April 27, 2009

Study Record Updates

• Last Update Posted (Estimate): July 9, 2009
• Last Update Submitted That Met QC Criteria: July 2, 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_582; MK0954-065