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EWISE: Study of Eplerenone in Women With Chest Pain, Coronary Vascular Dysfunction and Evidence of Myocardial Ischemia

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00187889
First received: September 10, 2005
Last updated: August 7, 2013
Last verified: October 2011
Results First Received: April 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Ischemic Heart Disease
Interventions: Drug: Eplerenone
Drug: Placebo or sugar pill

  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
The participants was recruited into the study by using flyers, and asked about interest in the medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 70 participants were screened for the study. Out of the 70 participants a total of 18 screened failed, 1 patient was withdrawn due to developing a spasm during the provocative testing screening which was believed to represent thrombosis and was not randomized to the study.

Reporting Groups
  Description
Eplerenone Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
Placebo or Sugar Pill Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.

Participant Flow:   Overall Study
    Eplerenone     Placebo or Sugar Pill  
STARTED     25     26  
COMPLETED     19     22  
NOT COMPLETED     6     4  
Withdrawal by Subject                 6                 4  



  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
Epleranone Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
Placebo or Sugar Pill Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
Total Total of all reporting groups

Baseline Measures
    Epleranone     Placebo or Sugar Pill     Total  
Number of Participants  
[units: participants]
  25     26     51  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     22     22     44  
>=65 years     3     4     7  
Age  
[units: years]
Mean ± Standard Deviation
  53  ± 9     54  ± 11     53  ± 10  
Gender  
[units: participants]
     
Female     25     26     51  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     25     26     51  



  Outcome Measures
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1.  Primary:   Epicardial Coronary Artery Endothelial Function (Adjusted) at Week 16 Comparing the Eplerenone Group to the Placebo Group   [ Time Frame: 16 weeks ]

2.  Secondary:   Microvascular Coronary Flow Reserve(Adjusted) at Week 16 Adjusted for Baseline Coronary Flow Reserve Comparing the Eplerenone Group to the Placebo Group   [ Time Frame: 16 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Carl J. Pepine
Organization: University of Florida
phone: 352-273-9082
e-mail: carl.pepine@medicine.ufl.edu


No publications provided by University of Florida

Publications automatically indexed to this study:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00187889     History of Changes
Other Study ID Numbers: EWISE, R01 H267173-01
Study First Received: September 10, 2005
Results First Received: April 25, 2013
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board