A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01307033
First received: March 1, 2011
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: November 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: MK-0954A
Drug: MK-954H
Drug: Placebo to MK-0954A
Drug: Placebo to MK-954H

  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
MK-0954H (L50/H12.5) Double Blind Period (Period 1) One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
MK-0954A (L100/H12.5) Double Blind Period (Period 1) One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
L50/H12.5→L100/H12.5 Open Label (Period 2) One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
L100/H12.5→L100/H12.5 Open Label (Period 2) One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension

Participant Flow for 2 periods

Period 1:   8-week Double-blind Period
    MK-0954H (L50/H12.5) Double Blind Period (Period 1)     MK-0954A (L100/H12.5) Double Blind Period (Period 1)     L50/H12.5→L100/H12.5 Open Label (Period 2)     L100/H12.5→L100/H12.5 Open Label (Period 2)  
STARTED     144     134     0     0  
COMPLETED     131     127     0     0  
NOT COMPLETED     13     7     0     0  
Adverse Event                 2                 0                 0                 0  
Withdrawal by Subject                 4                 1                 0                 0  
Lack of Efficacy                 1                 0                 0                 0  
Blood Pressure Withdrawal Criteria Met                 0                 3                 0                 0  
Potassium Withdrawal Criteria Met                 6                 3                 0                 0  

Period 2:   44-week Open-label Extension
    MK-0954H (L50/H12.5) Double Blind Period (Period 1)     MK-0954A (L100/H12.5) Double Blind Period (Period 1)     L50/H12.5→L100/H12.5 Open Label (Period 2)     L100/H12.5→L100/H12.5 Open Label (Period 2)  
STARTED     0     0     131     127  
COMPLETED     0     0     120     115  
NOT COMPLETED     0     0     11     12  
Adverse Event                 0                 0                 2                 1  
Withdrawal by Subject                 0                 0                 2                 1  
Physician Decision                 0                 0                 1                 0  
Blood Pressure Withdrawal Criteria Met                 0                 0                 0                 2  
Potassium Withdrawal Criteria Met                 0                 0                 6                 7  
Death                 0                 0                 0                 1  



  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
MK-0954H (L50/H12.5) One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
MK-0954A (L100/H12.5) One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension.
Total Total of all reporting groups

Baseline Measures
    MK-0954H (L50/H12.5)     MK-0954A (L100/H12.5)     Total  
Number of Participants  
[units: participants]
  144     134     278  
Age  
[units: Years]
Mean ± Standard Deviation
  56.9  ± 10.7     57.8  ± 10.8     57.3  ± 10.7  
Gender  
[units: Participants]
     
Female     41     32     73  
Male     103     102     205  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)   [ Time Frame: Up to 52 weeks ]

2.  Secondary:   Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8   [ Time Frame: Baseline and Week 8 (End of Double-blind Period) ]

3.  Secondary:   Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8   [ Time Frame: Baseline and Week 8 (End of Double-blind Period) ]


  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: Vice President, Late Stage Development Group Leader
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: NCT01307033     History of Changes
Other Study ID Numbers: 0954A-351
Study First Received: March 1, 2011
Results First Received: November 14, 2013
Last Updated: May 14, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency