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Trial record 26 of 112 for:    EPLERENONE

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

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ClinicalTrials.gov Identifier: NCT00187889
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ischemic Heart Disease
Interventions Drug: Eplerenone
Drug: Placebo or sugar pill
Enrollment 70
Recruitment Details The participants was recruited into the study by using flyers, and asked about interest in the medical clinics.
Pre-assignment Details 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 Out of the 70 participants a total of 18 screened failed, 1 patient was withdrawn due to developing a spasm during the provocative testing screening which was believed to represent thrombosis and was not randomized to the study.
Arm/Group Title Eplerenone Placebo or Sugar Pill
Hide Arm/Group Description Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks. Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
Period Title: Overall Study
Started 25 26
Completed 19 22
Not Completed 6 4
Reason Not Completed
Withdrawal by Subject             6             4
Arm/Group Title Epleranone Placebo or Sugar Pill Total
Hide Arm/Group Description Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks. Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks. Total of all reporting groups
Overall Number of Baseline Participants 25 26 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  88.0%
22
  84.6%
44
  86.3%
>=65 years
3
  12.0%
4
  15.4%
7
  13.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 26 participants 51 participants
53  (9) 54  (11) 53  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
Female
25
 100.0%
26
 100.0%
51
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 26 participants 51 participants
25 26 51
1.Primary Outcome
Title Epicardial Coronary Artery Endothelial Function (Adjusted) at Week 16 Comparing the Eplerenone Group to the Placebo Group
Hide Description The primary measure was the relative change in coronary diameter to acetylcholinem (ACH) at 16 weeks adjusted for baseline reactivity to acetylcholine. Change in coronary artery diameter after ACH was measured in mm at baseline and 16 weeks. Percent change at 16 weeks - percent change at baseline was the outcome.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
power analysis: Study planned to detect a 12% difference in change from baseline to 16 weeks between treatment groups (SD=14%), in the primary outcome leading to a planned sample size of 22 per group (44 total) for 80% power, P=0.05 2-sided. Study allowed for 6 dropouts, leading to a final N=50 planned (25 per group). Per protocol analysis used.
Arm/Group Title EPLERINONE PLACEBO
Hide Arm/Group Description:
Active drug
Inert Placebo
Overall Number of Participants Analyzed 19 22
Mean (Standard Deviation)
Unit of Measure: % change wk16-%change wk0- unitless
-1.2  (15.4) -10.7  (25.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EPLERINONE, PLACEBO
Comments The null hypothesis is that the treatments are equivalent with respect to the primary outcome. The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments The P-value applies to this comparison, without adjustment, to the completers of the trial.
Method Satterthwaite corrected t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.6
Confidence Interval (2-Sided) 95%
-22.8 to 3.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.7
Estimation Comments An expanded definition of the outcome measure is the difference between the percentage change (week 16) and the percentage change week 0). This is a calculation based on 4 measurements.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EPLERINONE, PLACEBO
Comments The null hypothesis is that treatments are equivalent on this outcome. The study was powered around the primary outcome. No adjustment for multiple comparisons was planned.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Satterthwaite corrected t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.79 to 0.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.39
Estimation Comments The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups. This is a different outcome variable than the primary.
2.Secondary Outcome
Title Microvascular Coronary Flow Reserve(Adjusted) at Week 16 Adjusted for Baseline Coronary Flow Reserve Comparing the Eplerenone Group to the Placebo Group
Hide Description Coronary flow reserve is a ratio of coronary blood flow velocity before and after adenosine. The outcome measure is the difference between the coronary flow reserve at 16 weeks adjusted for coronary flow reserve at baseline.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
See Primary Outcome. The studied was only powered for the primary outcome. All completers are included per protocol analysis.
Arm/Group Title EPLERENONE PLACEBO
Hide Arm/Group Description:
Active Drug
Inert Placebo
Overall Number of Participants Analyzed 13 18
Mean (Standard Deviation)
Unit of Measure: difference of ratios (unitless)
-0.4  (0.9) -0.4  (1.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epleranone Placebo or Sugar Pill
Hide Arm/Group Description Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks. Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
All-Cause Mortality
Epleranone Placebo or Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Epleranone Placebo or Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/24 (4.17%)      0/26 (0.00%)    
Vascular disorders     
Deep venous thrombosis  1 [1]  1/24 (4.17%)  1 0/26 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
[1]
Day 17 hospitalized for DVT, anticoagulated with coumadin,recovered uneventfully. DVT occurred in the leg that cath was performed consider possible related, patient on placebo.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Epleranone Placebo or Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/24 (12.50%)      3/26 (11.54%)    
Cardiac disorders     
chest pain  1  3/24 (12.50%)  3 3/26 (11.54%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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
Layout table for Results Point of Contact information
Name/Title: Dr. Carl J. Pepine
Organization: University of Florida
Phone: 352-273-9082
EMail: carl.pepine@medicine.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00187889     History of Changes
Other Study ID Numbers: EWISE
R01 H267173-01
First Submitted: September 10, 2005
First Posted: September 16, 2005
Results First Submitted: April 25, 2013
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013