A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)

Merck Sharp & Dohme LLC122 enrolled

Overview

The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

122

Conditions

Hypertension

Interventions

losartan potassiumDRUG

losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

Comparator: placeboDRUG

placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

hydrochlorothiazide (HCTZ)DRUG

open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-black men and women with mild to moderate hypertension and within 30% of their ideal body weight * Patient is in good general health * Blood pressure at time of randomization is 95-115 mm Hg Exclusion Criteria: * Secondary Hypertension or history of malignant hypertension * History of stroke * History of myocardial infarction * Atrial flutter or atrial fibrillation * History of congestive Heart failure * Patient taking major psychotropic agent or anti-depressant * Patient regularly uses NSAIDS or high dose aspirin * Known positive test for HIV/AIDS or Hepatitis B * Patient is being treated for acute ulcer disease * Prior exposure to losartan * Actively treated diabetes mellitus * History of chronic liver disease * Actively treated diabetes mellitus * Any known bleeding or platelet disorder * Absence of one kidney * Women of childbearing potential * Alcoholism or drug addiction

Outcomes

Primary Outcomes

Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4

Time frame: 24 hour period at Baseline and Week 4

Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4

Time frame: 24-hour period at baseline and Week 4

Secondary Outcomes

Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4

Time frame: Baseline and 24-hours after morning dose at Week 4

Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6

Time frame: Baseline and 24-hours after morning dose at Week 6

Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6

Time frame: Baseline and 24-hours after morning dose at Week 6

Data from ClinicalTrials.gov

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