MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

Merck Sharp & Dohme LLC428 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

428

Conditions

Hypertension

Interventions

losartan potassiumDRUG

losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks

Comparator: placeboDRUG

placebo to losartan tablet q.a.m. , for 12 weeks

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.