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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: March 30, 2017
Last verified: March 2017
Results First Received: March 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 168   166   334 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (10.5)   51.8  (10.6)   52.9  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      42  25.0%      36  21.7%      78  23.4% 
Male      126  75.0%      130  78.3%      256  76.6% 


  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



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: March 30, 2017