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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.
Results First Submitted: May 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: losartan potassium
Drug: Comparator: losartan
Drug: Comparator: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at 22 sites in the United States. Prime Therapy Period: December, 1991 to August, 1992.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients could be randomized after the 4-week placebo baseline period if their mean sitting diastolic blood pressure (SiDBP) was 95-115 mm Hg and ≤7 mm Hg from the mean SiDBP after 2 weeks of placebo therapy

Reporting Groups
  Description
Placebo Losartan placebo orally once daily for 12 weeks
Losartan 50 mg Losartan 50 mg orally once daily for 12 weeks
Losartan 50/100 mg Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks

Participant Flow:   Overall Study
    Placebo   Losartan 50 mg   Losartan 50/100 mg
STARTED   116   127   123 
COMPLETED   98   115   110 
NOT COMPLETED   18   12   13 
Adverse Event                3                0                7 
Lack of Efficacy                9                6                1 
Lost to Follow-up                2                3                1 
Protocol Violation                2                2                1 
Withdrawal by Subject                2                1                2 
Patient uncooperative                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Losartan placebo orally once daily for 12 weeks
Losartan 50 mg Losartan 50 mg orally once daily for 12 weeks
Losartan 50/100 mg Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo   Losartan 50 mg   Losartan 50/100 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 116   127   123   366 
Age 
[Units: Years]
Mean (Full Range)
 53.8 
 (26 to 78) 
 53.2 
 (28 to 75) 
 55.1 
 (28 to 76) 
 54.0 
 (26 to 78) 
Gender 
[Units: Participants]
       
Female   42   44   45   131 
Male   74   83   78   235 
Race/Ethnicity, Customized 
[Units: Participants]
       
Caucasian   92   104   101   297 
Black   17   14   16   47 
Hispanic   7   8   4   19 
Indian   0   1   0   1 
Oriental   0   0   2   2 
Sitting Diastolic Blood Pressure (SiDBP) 
[Units: Mm Hg]
Mean (Full Range)
 101.3 
 (95 to 115) 
 102.2 
 (95 to 113) 
 102.2 
 (95 to 114) 
 101.9 
 (95 to 114) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6   [ Time Frame: 24 hours post dose at Week 6 ]

3.  Secondary:   Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12   [ Time Frame: 24 hours post dose at Week 12 ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]

6.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Safety has been reported in the literature.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372



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
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: May 7, 2009
Results First Posted: June 24, 2009
Last Update Posted: July 29, 2009