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Diurnal Variation of Plasminogen Activator Inhibitor-1

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ClinicalTrials.gov Identifier: NCT00515021
Recruitment Status : Completed
First Posted : August 13, 2007
Results First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
James Muldowney, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Metabolic Syndrome X
Interventions Drug: Eplerenone (Morning)
Drug: Eplerenone (Night-time)
Enrollment 21
Recruitment Details  
Pre-assignment Details 1 participant withdrew prior to randomization
Arm/Group Title Eplerenone: Morning Administration Then Evening Eplerenone: Evening Administration Then Morning
Hide Arm/Group Description

Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks

Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg

Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks

Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks

Period Title: Overall Study
Started 9 11
Completed 9 11
Not Completed 0 0
Arm/Group Title Eplerenone: Morning Administration Then Evening Eplerenone: Evening Administration Then Morning Total
Hide Arm/Group Description

Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks

Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg

Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks

Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks

Total of all reporting groups
Overall Number of Baseline Participants 9 11 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
11
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Female
5
  55.6%
5
  45.5%
10
  50.0%
Male
4
  44.4%
6
  54.5%
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 11 participants 20 participants
10 10 20
1.Primary Outcome
Title Plasminogen Activator Inhibitor-1 (PAI-1) Levels
Hide Description baseline PAI-1 levels prior to drug administration
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone: Morning Administration Then Evening Eplerenone: Evening Administration Then Morning
Hide Arm/Group Description:

Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks

Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg

Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks

Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: ng/ml
41.5  (17.9) 42.9  (10.5)
2.Primary Outcome
Title Plasminogen Activator Inhibitor-1 (PAI-1) Levels
Hide Description PAI-1 levels after Eplerenone 50mg daily for 2 weeks then 100mg daily for 4 weeks. Time of administration varied in the arms, either morning or night time dosing.
Time Frame after 6 weeks on Eplerenone
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eplerenone: Morning Administration Eplerenone: Night-time Administration
Hide Arm/Group Description:
Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks
Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: ng/ml
39.9  (4.0) 40.4  (3.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eplerenone: Morning Administration Then Evening Eplerenone: Evening Administration Then Morning
Hide Arm/Group Description

Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks

Eplerenone - 50mg, by mouth, daily in the evening x 2 weeks followed by 4 weeks at 100mg

Eplerenone 50mg, by mouth, daily, in the evening for 2 weeks followed by 100mg, by mouth, daily, in the evening x 4 weeks

Eplerenone - 50mg, by mouth, daily, in the morning for 2 weeks followed by 100mg, by mouth, daily, in the morning x 4 weeks

All-Cause Mortality
Eplerenone: Morning Administration Then Evening Eplerenone: Evening Administration Then Morning
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Eplerenone: Morning Administration Then Evening Eplerenone: Evening Administration Then Morning
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eplerenone: Morning Administration Then Evening Eplerenone: Evening Administration Then Morning
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (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 Medical Center
ClinicalTrials.gov Identifier: NCT00515021     History of Changes
Other Study ID Numbers: 070183
First Submitted: August 9, 2007
First Posted: August 13, 2007
Results First Submitted: March 16, 2017
Results First Posted: February 1, 2019
Last Update Posted: February 1, 2019