MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00888355
First received: April 24, 2009
Last updated: July 2, 2009
Last verified: July 2009

April 24, 2009
July 2, 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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ 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 after last morning dose) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of patients with clinical adverse experiences (CAEs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with serious CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with drug-related CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients discontinued due to CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients who died [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with laboratory adverse experiences (LAEs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with serious LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with drug-related LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients discontinued due to LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00888355
2009_582, MK0954-065
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