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A Study to Investigate the Antihypertensive Efficacy of MK0954

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00887250
First Posted: April 23, 2009
Last Update Posted: July 29, 2009
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:
Merck Sharp & Dohme Corp.
April 22, 2009
April 23, 2009
May 7, 2009
June 24, 2009
July 29, 2009
December 1991
August 1992   (Final data collection date for primary outcome measure)
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) ]
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 24 hours post dose at 12 weeks ]
Complete list of historical versions of study NCT00887250 on ClinicalTrials.gov Archive Site
  • Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 [ Time Frame: 24 hours post dose at Week 6 ]
  • Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 24 hours post dose at Week 12 ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6 [ Time Frame: 24 hours post dose at Week 6 ]
  • Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 24 hours post dose at Week 12 ]
  • Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6 [ Time Frame: 24 hours post dose at Week 6 ]
  • Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6 [ Time Frame: 24 hours post dose at Week 6 ]
  • Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 6 hours post dose at Week 12 ]
Not Provided
Not Provided
 
A Study to Investigate the Antihypertensive Efficacy of MK0954
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: losartan potassium
    50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.
    Other Name: MK0954
  • 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
  • Drug: Comparator: Placebo
    Placebo to Losartan
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Comparator: Placebo
  • Experimental: 2
    Losartan 50 mg for 12 weeks
    Intervention: Drug: losartan potassium
  • Experimental: 3
    Losartan 50 mg titrated to 100 mg after 6 weeks
    Intervention: Drug: Comparator: losartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
November 1992
August 1992   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00887250
2009_580
MK0954-050
Not Provided
Not Provided
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP