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MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01299376
First received: February 16, 2011
Last updated: December 1, 2016
Last verified: November 2016
Results First Received: December 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: L50/H12.5/A5
Drug: L50/H12.5
Drug: Placebo to L50/H12.5/A5
Drug: Placebo to L50/H12.5

  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)/hydrochlorothiazide 12.5 mg (H12.5) and placebo for L50/H12.5/amlodipine 5 mg (A5) during 8-week Filter Period. A total of 510 entered the Filter Period and 286 were randomly assigned to 1 of the 2 treatment arms for the Double-blind Treatment Period.

Reporting Groups
  Description
L50/H12.5/A5→L50/H12.5/A5 One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
L50/H12.5→L50/H12.5/A5 One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.

Participant Flow for 2 periods

Period 1:   Double-blind Treatment (Weeks 1 to 8)
    L50/H12.5/A5→L50/H12.5/A5   L50/H12.5→L50/H12.5/A5
STARTED   141   145 
COMPLETED   134   133 
NOT COMPLETED   7   12 
Adverse Event                1                2 
Lack of Efficacy                0                1 
Lost to Follow-up                0                1 
Blood Pressure/Potassium Criteria Met                4                7 
Protocol Violation                1                0 
Withdrawal by Subject                1                1 

Period 2:   Extension (Weeks 9 to 52)
    L50/H12.5/A5→L50/H12.5/A5   L50/H12.5→L50/H12.5/A5
STARTED   134   133 
COMPLETED   124   118 
NOT COMPLETED   10   15 
Withdrawal by Subject                2                1 
Adverse Event                2                3 
Lost to Follow-up                1                2 
Blood Pressure/Potassium Criteria Met                4                9 
Physician Decision                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→L50/H12.5/A5 One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
L50/H12.5→L50/H12.5/A5 One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
Total Total of all reporting groups

Baseline Measures
   L50/H12.5/A5→L50/H12.5/A5   L50/H12.5→L50/H12.5/A5   Total 
Overall Participants Analyzed 
[Units: Participants]
 141   145   286 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.9  (9.1)   56.3  (9.7)   55.1  (9.5) 
Gender 
[Units: Participants]
Count of Participants
     
Female      33  23.4%      34  23.4%      67  23.4% 
Male      108  76.6%      111  76.6%      219  76.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period   [ Time Frame: Baseline and Week 8 ]

2.  Primary:   Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period   [ Time Frame: up to Week 8 ]

3.  Primary:   Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period   [ Time Frame: up to Week 8 ]

4.  Primary:   Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period   [ Time Frame: up to Week 8 ]

5.  Primary:   Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period   [ Time Frame: up to Week 8 ]

6.  Primary:   Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period   [ Time Frame: up to Week 8 ]

7.  Primary:   Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term   [ Time Frame: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 ]

8.  Primary:   Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term   [ Time Frame: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 ]

9.  Primary:   Percentage of Participants Who Experience 1 or More SAEs- Long Term   [ Time Frame: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 ]

10.  Primary:   Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term   [ Time Frame: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 ]

11.  Primary:   Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term   [ Time Frame: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5 ]

12.  Secondary:   Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period   [ 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
No text entered.


  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: NCT01299376     History of Changes
Other Study ID Numbers: 0954E-356
Study First Received: February 16, 2011
Results First Received: December 1, 2016
Last Updated: December 1, 2016