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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
Results First Received: May 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: losartan potassium
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 37 sites in the United States. Prime Therapy Period: May, 1992 to January1993

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients could be randomized if sitting diastolic blood pressure (SiDBP) after 2 and 4 weeks of placebo washout was 95-115 mm Hg and the difference between measurements at the 2 visits did not differ by >7 mm Hg.

Reporting Groups
  Description
Placebo Losartan placebo orally once daily for 12 weeks
Losartan 25 mg q.d. Losartan 25 mg orally once daily (q.d.) for 12 weeks
Losartan 50 mg q.d. Losartan 50 mg orally once daily (q.d.) for 12 weeks
Losartan 25 mg (b.i.d.) Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks

Participant Flow:   Overall Study
    Placebo   Losartan 25 mg q.d.   Losartan 50 mg q.d.   Losartan 25 mg (b.i.d.)
STARTED   108   108   106   106 
COMPLETED   86   99   94   96 
NOT COMPLETED   22   9   12   10 
Adverse Event                10                0                3                3 
Lack of Efficacy                9                2                5                2 
Lost to Follow-up                0                2                2                0 
Protocol Violation                3                2                1                2 
Withdrawal by Subject                0                3                1                3 



  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 25 mg q.d. Losartan 25 mg orally once daily (q.d.) for 12 weeks
Losartan 50 mg q.d. Losartan 50 mg orally once daily (q.d.) for 12 weeks
Losartan 25 mg (b.i.d.) Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo   Losartan 25 mg q.d.   Losartan 50 mg q.d.   Losartan 25 mg (b.i.d.)   Total 
Overall Participants Analyzed 
[Units: Participants]
 108   108   106   106   428 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.6  (10.6)   53.0  (10.7)   54.0  (10.1)   52.4  (10.1)   53.5  (10.4) 
Gender 
[Units: Participants]
         
Female   38   41   36   36   151 
Male   70   67   70   70   277 
Race/Ethnicity, Customized 
[Units: Participants]
         
Caucasian   84   79   82   89   334 
Oriental   1   2   2   2   7 
Latin American   0   1   0   0   1 
Black   21   22   17   10   70 
Hispanic   2   4   5   4   15 
Vietnamese   0   0   0   1   1 
Sitting Diastolic Blood Pressure (SiDBP) 
[Units: Mm Hg]
Mean (Standard Deviation)
 101.5  (5.1)   101.8  (5.5)   102.4  (6.4)   102.0  (5.3)   101.9  (5.6) 


  Outcome Measures
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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 after last morning dose and 12 hours after last PM dose) ]

2.  Secondary:   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) ]

3.  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 after last morning dose) ]

4.  Secondary:   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 ]

5.  Other Pre-specified:   Number of Patients With Clinical Adverse Experiences (CAEs)   [ Time Frame: 12 weeks ]

6.  Other Pre-specified:   Number of Patients With Serious CAEs   [ Time Frame: 12 weeks ]

7.  Other Pre-specified:   Number of Patients With Drug-related CAEs   [ Time Frame: 12 weeks ]

8.  Other Pre-specified:   Number of Patients Discontinued Due to CAEs   [ Time Frame: 12 weeks ]

9.  Other Pre-specified:   Number of Patients Who Died   [ Time Frame: 12 weeks ]

10.  Other Pre-specified:   Number of Patients With Laboratory Adverse Experiences (LAEs)   [ Time Frame: 12 weeks ]

11.  Other Pre-specified:   Number of Patients With Serious LAEs   [ Time Frame: 12 weeks ]

12.  Other Pre-specified:   Number of Patients With Drug-related LAEs   [ Time Frame: 12 weeks ]

13.  Other Pre-specified:   Number of Patients Discontinued Due to LAEs   [ Time Frame: 12 weeks ]


  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
Note that deaths are not entered under "drop reasons" in the participant flow panel because the patients who died are already counted as dropped due to adverse event.


  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: NCT00888355     History of Changes
Other Study ID Numbers: 2009_582
MK0954-065
Study First Received: April 24, 2009
Results First Received: May 7, 2009
Last Updated: July 2, 2009
Health Authority: United States: Food and Drug Administration