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Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes

This study has been terminated.
(Lack of funding)
Sponsor:
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Stephen N. Davis, University of Maryland
ClinicalTrials.gov Identifier:
NCT00574834
First received: December 13, 2007
Last updated: June 29, 2016
Last verified: June 2016
Results First Received: December 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Metabolic Syndrome
Interventions: Drug: Ramipril
Drug: HCTZ-hydrochlorothiazide
Drug: Ramipril+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
Individuals with pre-diabetes (metabolic syndrome) are recruited for a 6 month study intervention.

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
Ramipril

Patients randomized to 6 months treatment of Ramipril.

Ramipril: Ramipril 20 mg once daily for 6 months

HCTZ

Patients randomized to 6 months treatment of HCTZ.

HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months

Ramipril+HCTZ

Patients randomized to 6 months treatment of Ramipril+HCTZ.

Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months


Participant Flow:   Overall Study
    Ramipril     HCTZ     Ramipril+HCTZ  
STARTED     9     4     4  
COMPLETED     9     4     4  
NOT COMPLETED     0     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
Ramipril

Patients randomized to 6 months treatment of Ramipril.

Ramipril: Ramipril 20 mg once daily for 6 months

HCTZ

Patients randomized to 6 months treatment of HCTZ.

HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months

Ramipril+HCTZ

Patients randomized to 6 months treatment of Ramipril+HCTZ.

Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months

Total Total of all reporting groups

Baseline Measures
    Ramipril     HCTZ     Ramipril+HCTZ     Total  
Number of Participants  
[units: participants]
  9     4     4     17  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     9     4     4     17  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  49  (8.5)     46  (9)     41  (13)     46  (10)  
Gender  
[units: participants]
       
Female     3     3     2     8  
Male     6     1     2     9  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     3     1     2     6  
White     6     3     2     11  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     9     4     4     17  



  Outcome Measures

1.  Primary:   Changes in Insulin Sensitivity   [ Time Frame: 6 months ]


  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
Early termination leading to small numbers of subjects analyzed. No conclusions drawn.


  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: Stephen N. Davis, MBBS- Principal Investigator
Organization: University of Maryland Baltimore
phone: 410-328-2488
e-mail: sdavis@medicine.umaryland.edu



Responsible Party: Stephen N. Davis, University of Maryland
ClinicalTrials.gov Identifier: NCT00574834     History of Changes
Other Study ID Numbers: HP-00044872-Ramipril
Study First Received: December 13, 2007
Results First Received: December 10, 2015
Last Updated: June 29, 2016
Health Authority: United States: Institutional Review Board