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MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888355
First Posted: April 27, 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 24, 2009
April 27, 2009
May 7, 2009
June 24, 2009
July 29, 2009
May 1992
January 1993   (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 after last morning dose and 12 hours after last PM dose) ]
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks ]
Complete list of historical versions of study NCT00888355 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 [ Time Frame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM 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 after last morning dose) ]
  • Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks ]
  • Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 [ Time Frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks ]
  • Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 6 hours after last morning dose at 12 weeks ]
  • Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks ]
  • Number of patients with clinical adverse experiences (CAEs) [ Time Frame: 12 weeks ]
  • Number of patients with serious CAEs [ Time Frame: 12 weeks ]
  • Number of patients with drug-related CAEs [ Time Frame: 12 weeks ]
  • Number of patients discontinued due to CAEs [ Time Frame: 12 weeks ]
  • Number of patients who died [ Time Frame: 12 weeks ]
  • Number of patients with laboratory adverse experiences (LAEs) [ Time Frame: 12 weeks ]
  • Number of patients with serious LAEs [ Time Frame: 12 weeks ]
  • Number of patients with drug-related LAEs [ Time Frame: 12 weeks ]
  • Number of patients discontinued due to LAEs [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension
A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Losartan Given Once or Twice Daily in Patients With Mild to Moderate Hypertension
The study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. Patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of Losartan.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: losartan potassium
    losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks
    Other Name: MK0954
  • Drug: Comparator: placebo
    placebo to losartan tablet q.a.m. , for 12 weeks
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Comparator: placebo
  • Experimental: 2
    Losartan 50 q.a.m.
    Intervention: Drug: losartan potassium
  • Experimental: 3
    Losartan 25 b.i.d.
    Intervention: Drug: losartan potassium
  • Experimental: 4
    Losartan 25 q.a.m.
    Intervention: Drug: losartan potassium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
428
February 1993
January 1993   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has been diagnosed with mild to moderate hypertension
  • Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure

Exclusion Criteria:

  • Pregnant of lactating female patients
  • Secondary hypertension or history of malignant hypertension
  • Sitting systolic blood pressure > 210 mmHg
  • History of stroke
  • History of myocardial infarction with in the past year
  • Current of prior history of heart failure
  • Known hypersensitivity to losartan
  • Obesity
  • Patients known to be HIV positive or known to be positive for Hepatitis B
  • Absence of one kidney
  • Patient is abusing or previously abused alcohol or drugs with in past two 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
 
 
NCT00888355
2009_582
MK0954-065
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