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A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01431508
First received: September 7, 2011
Last updated: October 13, 2011
Last verified: October 2011
Results First Received: October 13, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Drug: Losartan 50 mg / HCTZ 12.5 mg

  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 50 mg / HCTZ 12.5 mg Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.

Participant Flow:   Overall Study
    Losartan 50 mg / HCTZ 12.5 mg  
STARTED     15  
COMPLETED     13  
NOT COMPLETED     2  
Lack of Efficacy                 1  
Unable to Follow Protocol Procedures                 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
Losartan 50 mg / HCTZ 12.5 mg Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.

Baseline Measures
    Losartan 50 mg / HCTZ 12.5 mg  
Number of Participants  
[units: participants]
  15  
Age  
[units: years]
Mean ± Standard Deviation
  50.5  ± 6.7  
Gender  
[units: participants]
 
Female     6  
Male     9  



  Outcome Measures

1.  Primary:   Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12   [ Time Frame: At Baseline and Week 12 ]


  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: NCT01431508     History of Changes
Other Study ID Numbers: MK-0954A-373
Study First Received: September 7, 2011
Results First Received: October 13, 2011
Last Updated: October 13, 2011
Health Authority: Taiwan: Institutional Review Board