We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00882440
First Posted: April 16, 2009
Last Update Posted: August 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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 ]
    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.

  • 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 ]

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882440


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00882440     History of Changes
Other Study ID Numbers: 0954-011
MK0954-011
2009_574
First Submitted: April 14, 2009
First Posted: April 16, 2009
Results First Submitted: April 17, 2009
Results First Posted: June 10, 2009
Last Update Posted: August 27, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Losartan
Enalapril
Enalaprilat
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors