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Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01277822
First received: January 13, 2011
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: March 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Losartan (+) amlodipine
Drug: Placebo to match losartan/amlodipine tablets
Drug: Amlodipine camsylate
Drug: Placebo to match amlodipine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Losartan/Amlodipine One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
Amlodipine 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.

Participant Flow:   Overall Study
    Losartan/Amlodipine     Amlodipine  
STARTED     168     166  
COMPLETED     153     155  
NOT COMPLETED     15     11  
Adverse Event                 2                 1  
Withdrawal by Subject                 6                 7  
Physician Decision                 1                 1  
Protocol Violation                 1                 0  
Lost to Follow-up                 2                 1  
Contraindicated medication used                 2                 1  
Participant moved                 1                 0  



  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.
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Reporting Groups
  Description
Losartan/Amlodipine One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
Amlodipine 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Losartan/Amlodipine     Amlodipine     Total  
Number of Participants  
[units: participants]
  168     166     334  
Age  
[units: years]
Mean ± Standard Deviation
  54  ± 10.5     51.8  ± 10.6     52.9  ± 10.6  
Gender  
[units: Participants]
     
Female     42     36     78  
Male     126     130     256  



  Outcome Measures
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1.  Primary:   Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4   [ Time Frame: Baseline and Week 4 ]

3.  Secondary:   Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8   [ Time Frame: Baseline and Week 8 ]

4.  Secondary:   Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4   [ Time Frame: Baseline and Week 4 ]

5.  Secondary:   Percentage of Participants Who Achieve Target Blood Pressure at Week 8   [ Time Frame: Week 8 ]

6.  Secondary:   Percentage of Participants Who Achieve Target Blood Pressure at Week 4   [ Time Frame: Week 4 ]

7.  Secondary:   Percentage of Participants Who Had Peripheral Edema During the Study   [ Time Frame: up to 8 weeks ]

8.  Secondary:   Change From Baseline in Ankle Circumference at Week 8   [ Time Frame: Baseline and Week 8 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01277822     History of Changes
Other Study ID Numbers: 0954F-399
Study First Received: January 13, 2011
Results First Received: March 24, 2014
Last Updated: May 19, 2014
Health Authority: Korea: Institutional Review Board