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Obese Hypertension Study (0954-315)

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ClinicalTrials.gov Identifier: NCT00289887
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : May 27, 2010
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Comparator: losartan +/- HCTZ
Drug: Comparator: Placebo

  Participant Flow

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 51 sites in the United States.

Prime Therapy Period: April 2006 to February 2007


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior antihypertensive medications were withdrawn/ tapered before patients entered the 4-week placebo run-in period.

Reporting Groups
  Description
Losartan Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Placebo Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg

Participant Flow:   Overall Study
    Losartan   Placebo
STARTED   127   134 
COMPLETED   105   105 
NOT COMPLETED   22   29 
Adverse Event                3                3 
Lack of Efficacy                3                11 
Lost to Follow-up                3                3 
Protocol Violation                3                1 
Withdrawal by Subject                3                8 
Other                7                3 



  Baseline Characteristics

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
Losartan Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
Placebo Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
Total Total of all reporting groups

Baseline Measures
   Losartan   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 127   134   261 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.1  (10.4)   51.4  (9.7)   50.8  (10.0) 
Gender 
[Units: Participants]
     
Female   79   77   156 
Male   48   57   105 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   84   87   171 
Black   22   29   51 
Hispanic American   20   16   36 
Native American   0   1   1 
Other   1   1   2 
Sitting Diastolic Blood Pressure (SiDBP) 
[Units: Mm Hg]
Mean (Standard Deviation)
 99.1  (4.2)   99.0  (4.0)   99.0  (4.1) 
Sitting Systolic Blood Pressure (SiSBP) 
[Units: Mm Hg]
Mean (Standard Deviation)
 151.6  (8.2)   152.4  (9.0)   152.0  (8.6) 


  Outcome Measures

1.  Primary:   Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8   [ Time Frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

2.  Primary:   Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8   [ Time Frame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

3.  Primary:   Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12   [ Time Frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

4.  Primary:   Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12   [ Time Frame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

5.  Primary:   Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16   [ Time Frame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]

6.  Primary:   Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16   [ Time Frame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00289887     History of Changes
Other Study ID Numbers: 0954-315
MK0954-315
2006_002
First Submitted: February 8, 2006
First Posted: February 10, 2006
Results First Submitted: September 21, 2009
Results First Posted: May 27, 2010
Last Update Posted: July 28, 2015