Diurnal Variation of Plasminogen Activator Inhibitor-1

• 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: Vanderbilt University Medical Center
• 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

Participant Flow

Recruitment Details
Pre-assignment Details	1 participant withdrew prior to randomization

Arm/Group Title	Eplerenone: Morning Administration Then Evening	Eplerenone: Evening Administration Then Morning
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

Baseline Characteristics

Arm/Group Title		Eplerenone: Morning Administration Then Evening	Eplerenone: Evening Administration Then Morning	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Plasminogen Activator Inhibitor-1 (PAI-1) Levels
Description	baseline PAI-1 levels prior to drug administration
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eplerenone: Morning Administration Then Evening	Eplerenone: Evening Administration Then Morning
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eplerenone: Morning Administration	Eplerenone: Night-time Administration
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Eplerenone: Morning Administration Then Evening	Eplerenone: Evening Administration Then Morning
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%)
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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: James Muldowney
• Organization: Vanderbilt University Medical Center
• Phone: 615-936-1720
• EMail: james.muldowney@vanderbilt.edu

• Responsible Party: James Muldowney, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT00515021
• 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