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Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00871871
First received: March 27, 2009
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
Results First Received: February 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Hydrochlorothiazide (HCTZ)
Drug: Comparator: Placebo to HCTZ
Drug: Isosorbide mononitrate (ISMN)
Drug: Comparator: Placebo to ISMN

  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
Enrolled participants were place into two periods. 36 Part I participants received Hydrochlorothiazide (HCTZ) first, then placebo or placebo first, then HCTZ. A new group of 28 Part II participants received Isosorbide Mononitrate (ISMN) first, then placebo or placebo first, then ISMN.

Reporting Groups
  Description
HCTZ First, Then HCTZ Placebo Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
HCTZ Placebo First, Then HCTZ Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
ISMN First, Then ISMN Placebo Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
ISMN Placebo First, Then ISMN Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2

Participant Flow for 2 periods

 Period 1:   Part I
    HCTZ First, Then HCTZ Placebo     HCTZ Placebo First, Then HCTZ     ISMN First, Then ISMN Placebo     ISMN Placebo First, Then ISMN  
STARTED     18     18     0     0  
COMPLETED     15     15     0     0  
NOT COMPLETED     3     3     0     0  
Adverse Event                 0                 2                 0                 0  
Withdrawal by Subject                 3                 0                 0                 0  
Laboratory abnormality                 0                 1                 0                 0  

Period 2:   Part II
    HCTZ First, Then HCTZ Placebo     HCTZ Placebo First, Then HCTZ     ISMN First, Then ISMN Placebo     ISMN Placebo First, Then ISMN  
STARTED     0     0     13     15  
COMPLETED     0     0     9     11  
NOT COMPLETED     0     0     4     4  
Lack of Efficacy                 0                 0                 1                 0  
Withdrawal by Subject                 0                 0                 2                 1  
Adverse Event                 0                 0                 1                 2  
Protocol Violation                 0                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
All Part I Participants Part I Overall: Hydrochlorothiazide (HCTZ) in Period 1 followed by Placebo in Period 2 or Placebo in Period 1, followed by HCTZ in Period 2
All Part II Participants Part II Overall: Isosorbide mononitrate (ISMN)in Period 1, followed by placebo in Period 2 or placebo in Period 1, followed by ISMN in Period 2
Total Total of all reporting groups

Baseline Measures
    All Part I Participants     All Part II Participants     Total  
Number of Participants  
[units: participants]
 		  36     28     64  
Age  
[units: years]
Mean ( Full Range ) 		  57  
  ( 35 to 72 )   		  54  
  ( 37 to 73 )   		  55  
  ( 35 to 73 )  
Gender  
[units: participants]
 		     
Female     20     13     33  
Male     16     15     31  



  Outcome Measures
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1.  Primary:   Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)   [ Time Frame: 90 -120 minutes post-dose ]
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2.  Primary:   Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG)   [ Time Frame: 90 -120 minutes post-dose ]
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3.  Primary:   Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT)   [ Time Frame: 90 -120 minutes post-dose ]
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4.  Primary:   Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state   [ Time Frame: 90 -120 minutes post-dose ]
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5.  Secondary:   Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)   [ Time Frame: 90 -120 minutes post-dose ]
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6.  Secondary:   Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG)   [ Time Frame: 90 -120 minutes post-dose ]
  Show Outcome Measure 6

7.  Secondary:   Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT)   [ Time Frame: 90 -120 minutes post-dose ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00871871     History of Changes
Other Study ID Numbers: MK-0000-117, 2009_567
Study First Received: March 27, 2009
Results First Received: February 22, 2011
Last Updated: August 17, 2011
Health Authority: South Africa: Medicines Control Council