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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00882440
First received: April 14, 2009
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: losartan potassium
Drug: Placebo
Drug: Enalapril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Different Doses of DuP 753 (MK0954)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 [ Time Frame: 24 hours post dose at Week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 576
Study Start Date: December 1990
Study Completion Date: January 1992
Primary Completion Date: August 1991 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo capsule to losartan
Experimental: 2
Losartan 10 mg
Drug: losartan potassium
losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks
Other Names:
  • MK0954
  • Cozaar
Experimental: 3
Losartan 25 mg
Drug: losartan potassium
losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks
Other Names:
  • MK0954
  • Cozaar
Experimental: 4
Losartan 50 mg
Drug: losartan potassium
losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks
Other Names:
  • MK0954
  • Cozaar
Experimental: 5
Losartan 100 mg
Drug: losartan potassium
losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks
Other Names:
  • MK0954
  • Cozaar
Experimental: 6
Losartan 150 mg
Drug: losartan potassium
losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks
Other Names:
  • MK0954
  • Cozaar
Active Comparator: 7
Enalapril 20 mg
Drug: Enalapril
Enalapril 20 mg oral tablet taken once daily for 8 weeks
Other Name: Enalapril

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882440

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00882440     History of Changes
Other Study ID Numbers: 2009_574, MK0954-011
Study First Received: April 14, 2009
Results First Received: April 17, 2009
Last Updated: July 7, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Enalapril
Enalaprilat
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on April 22, 2014