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MK-0954E Study in Participants With Hypertension (MK-0954E-357)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01302691
First received: February 22, 2011
Last updated: December 5, 2016
Last verified: December 2016
Results First Received: December 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)
Drug: Losartan potassium
Drug: Amlodipine besylate
Drug: Placebo to MK-0954E
Drug: Placebo to losartan potassium
Drug: Placebo to amlodipine besylate

  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
All participants received single–blind losartan 50 mg (L50) + amlodipine 5 mg (A5) and placebo for L50/(H12.5)/A5 during 8-week Filter/Screening Period. A total of 707 entered the Filter/Screening Period and 327 were randomly assigned to 1 of the 2 treatment arms for the Double-blind Treatment Period.

Reporting Groups
  Description
L50/H12.5/A5 Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
L50 + A5 Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.

Participant Flow:   Overall Study
    L50/H12.5/A5   L50 + A5
STARTED   164   163 
COMPLETED   154   157 
NOT COMPLETED   10   6 
Adverse Event                2                0 
Death                0                1 
Lost to Follow-up                1                0 
Blood Pressure/Potassium Criteria Met                6                4 
Physician Decision                0                1 
Protocol Violation                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
L50/H12.5/A5 Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
L50 + A5 Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   L50/H12.5/A5   L50 + A5   Total 
Overall Participants Analyzed 
[Units: Participants]
 164   163   327 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.9  (9.4)   55.4  (10.1)   55.2  (9.7) 
Gender 
[Units: Participants]
Count of Participants
     
Female      33  20.1%      41  25.2%      74  22.6% 
Male      131  79.9%      122  74.8%      253  77.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP)   [ Time Frame: Baseline and Week 8 ]

2.  Primary:   Percentage of Participants Who Experience ≥1 Adverse Event (AE)   [ Time Frame: up to 14 days after last dose of study drug (up to 10 weeks) ]

3.  Primary:   Percentage of Participants Who Experience ≥1 Drug-related AE   [ Time Frame: up to 14 days after last dose of study drug (up to 10 weeks) ]

4.  Primary:   Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)   [ Time Frame: up to 14 days after last dose of study drug (up to 10 weeks) ]

5.  Primary:   Percentage of Participants Who Experience ≥1 Drug-related SAE   [ Time Frame: up to 14 days after last dose of study drug (up to 10 weeks) ]

6.  Primary:   Percentage of Participants Who Had Study Drug Stopped Due to an AE   [ Time Frame: up to 8 weeks ]

7.  Secondary:   Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP)   [ 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 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 of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01302691     History of Changes
Other Study ID Numbers: 0954E-357
Study First Received: February 22, 2011
Results First Received: December 5, 2016
Last Updated: December 5, 2016