Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00953680
First received: August 4, 2009
Last updated: September 10, 2010
Last verified: September 2010
Results First Received: May 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)
Drug: losartan potassium
Drug: hydrochlorothiazide (HCTZ)

  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-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet Single dose losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet

Participant Flow for 2 periods

Period 1:   Period 1
    Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule     Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet  
STARTED     38     39  
COMPLETED     38     38  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  

Period 2:   Period 2
    Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule     Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet  
STARTED     38     38  
COMPLETED     38     38  
NOT COMPLETED     0     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
All Participants All randomized patients

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  77  
Age  
[units: years]
Mean ( Full Range )
  33.87  
  ( 18 to 45 )  
Gender  
[units: participants]
 
Female     46  
Male     31  
Height  
[units: Centimeters]
Mean ( Full Range )
  166.81  
  ( 152 to 191 )  
Weight  
[units: kilograms]
Mean ( Full Range )
  73.01  
  ( 50 to 99.1 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Curve (AUC(0 to Infinity)) of Losartan   [ Time Frame: 0 to 36 Hours Post Dose ]

2.  Primary:   Peak Plasma Concentration (Cmax) for Losartan   [ Time Frame: 36 Hours Post Dose ]

3.  Primary:   Area Under the Curve (AUC(0 to Infinity)) of HCTZ   [ Time Frame: 0 to 30 Hours Post Dose ]

4.  Primary:   Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ   [ Time Frame: 30 Hours Post Dose ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
PK analyses included complete data from 75 subjects. 3 losartan/E-3174 concentrations from 3 different subjects were excluded from analyses due to gross deviations; 75 minutes-Treatment B, 75 minutes-Treatment A, & 15 minutes-Treatment A.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00953680     History of Changes
Other Study ID Numbers: 2009_628, MK0954A-306
Study First Received: August 4, 2009
Results First Received: May 13, 2010
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration