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A Study to Investigate the Antihypertensive Efficacy of MK0954

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00887250
First received: April 22, 2009
Last updated: July 8, 2009
Last verified: July 2009
History of Changes
  Purpose

After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. This study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan (MK954, DuP753) in Patients With Mild to

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome 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 post dose) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 [ Time Frame: 24 hours post dose at Week 6 ] [ Designated as safety issue: No ]
  • Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 24 hours post dose at Week 12 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6 [ Time Frame: At baseline and at 6 weeks (24 hours post dose) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6 [ Time Frame: At baseline and at 6 weeks (24 hours post dose) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: At baseline and at 12 weeks (6 hours post dose) ] [ Designated as safety issue: No ]

Enrollment: 366
Study Start Date: December 1991
Study Completion Date: November 1992
Primary Completion Date: August 1992 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: Comparator: Placebo
Placebo to Losartan
Experimental: 2
Losartan 50 mg for 12 weeks
 Drug: losartan potassium
50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.
Other Name: MK0954
Experimental: 3
Losartan 50 mg titrated to 100 mg after 6 weeks
 Drug: Comparator: losartan
50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.
Other Name: MK0954

  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 (SDBP 95-115 mm Hg)
  • Patient has no medical problems or treatments that might effect their blood pressure

Exclusion Criteria:

  • Pregnant or lactating females
  • Patient has secondary hypertension or malignant hypertension
  • Sitting systolic blood pressure > 210 mm Hg
  • History of stroke
  • History of myocardial infarction with in past year
  • Current or prior history of heart failure
  • Known hypersensitivity to losartan
  • Prior exposure to losartan
  • Patients known to be HIV positive
  • Patient is abusing or has abused alcohol or other drugs within the past 4 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887250

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00887250     History of Changes
Other Study ID Numbers: 2009_580, MK0954-050
Study First Received: April 22, 2009
Results First Received: May 7, 2009
Last Updated: July 8, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013