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Trial record 71 of 112 for:    EPLERENONE

Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00608465
Recruitment Status : Terminated (Lack of enrollment)
First Posted : February 6, 2008
Results First Posted : May 1, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
James Muldowney, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Metabolic Syndrome X
Interventions Drug: Eplerenone
Drug: Ramipril
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description The study was never unblinded as enrollment was never completed.
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description The study was never unblinded as enrollment was never completed.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Secreted Factors From Adipocytes Have Autocrine, Paracrine and Endocrine Effects That Have a Deleterious Effect on the Fibrinolytic System, Either by Enhancing PAI-1 Production or Impairing Endothelial t-PA Release
Hide Description [Not Specified]
Time Frame 10-Week period
Hide Outcome Measure Data
Hide Analysis Population Description
Enrollment was never completed so study was never unblinded and data was never analyzed
Arm/Group Title All Patients
Hide Arm/Group Description:
The study was never unblinded as enrollment was never completed.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title This Study Will Analyze Patients' Genetic Make up to Identify Who May be at Greater Risk for Heart Disease and Strokes in Relationship to High Blood Pressure and Central Obesity.
Hide Description [Not Specified]
Time Frame 10-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Enrollment was never completed so study was never unblinded and data was never analyzed
Arm/Group Title All Patients
Hide Arm/Group Description:
The study was never unblinded as enrollment was never completed.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description The study was never unblinded as enrollment was never completed.
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients
Affected / at Risk (%)
Total   0/4 (0.00%) 
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: James Muldowney
Organization: Vanderbilt University Medical Center
Phone: 615-936-1720
EMail: james.muldowney@vanderbilt.edu
Layout table for additonal information
Responsible Party: James Muldowney, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00608465     History of Changes
Other Study ID Numbers: 060369
060369
First Submitted: January 22, 2008
First Posted: February 6, 2008
Results First Submitted: March 16, 2017
Results First Posted: May 1, 2017
Last Update Posted: August 11, 2017