MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 1993

Interventions

  • Drug: losartan potassium
    • losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks
  • Drug: Comparator: placebo
    • placebo to losartan tablet q.a.m. , for 12 weeks

Arms, Groups and Cohorts

  • Placebo Comparator: 1
    • Placebo
  • Experimental: 2
    • Losartan 50 q.a.m.
  • Experimental: 3
    • Losartan 25 b.i.d.
  • Experimental: 4
    • Losartan 25 q.a.m.

Clinical Trial Outcome Measures

Primary Measures

  • Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (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)
    • 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

Secondary Measures

  • Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as 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 trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12
  • Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12
    • Time Frame: At baseline and at 12 weeks (6 hours after last morning dose)
    • Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12
  • Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
    • Time Frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

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