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Completed

NCT Number: NCT00882440

A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)

The purpose of this study was to compare the antihypertensive efficacy of different doses of losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure of 100-115 mmHg.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has been diagnosed with mild to moderate hypertension, with supine diastolic blood pressure of 100 to 115 mmHg
  • Patient has no active medical problems other than essential hypertension that might affect blood pressure
  • Patient has received no drug therapy that might affect blood pressure

Exclusion criteria

  • Prior exposure to losartan
  • History of stroke
  • History of myocardial infarction
  • Atrial flutter or atrial fibrillation
  • History of congestive Heart failure
  • Known Sensitivity to ACE inhibitors
  • Known positive test for HIV/AIDS or Hepatitis B
  • Patient is being treated for acute ulcer disease
  • History of chronic liver disease
  • Actively treated diabetes mellitis
  • Any known bleeding or platelet disorder
  • Absence of one kidney
  • Women of childbearing potential or who are breastfeeding
  • Patient is abusing or has a history of alcoholism or drug addiction

Treatment and study plan

Losartan Potassium

Drug

losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks

Other names: MK0954, Cozaar

Placebo

Drug

Placebo capsule to losartan

Enalapril

Drug

Enalapril 20 mg oral tablet taken once daily for 8 weeks

Primary outcomes

  1. Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8

    Time frame: 24 hours post dose at Baseline and Week 8

Secondary outcomes

  1. Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8

    Time frame: 24 hours post dose at Week 8

    Patients in Category I (defined as "excellent" in protocol) if SuDBP was <90 mmHg, Category II (defined as "good" in protocol) if SuDBP was ≥90 but decreased at least 10 mmHg, or Category III (defined as "fair" or "inadequate" in protocol) if SuDBP was ≥90 and decreased less than 10 mmHg.

  2. Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8

    Time frame: 6 hours post dose at Baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Different Doses of DuP 753 (MK0954)

Important dates

Study start
1990
Primary completion
1991
Study completion
1992
First posted
Apr 16, 2009
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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