Trial Outcomes & Findings for Diurnal Variation of Plasminogen Activator Inhibitor-1 (NCT NCT00515021)

NCT ID: NCT00515021

Last Updated: 2019-02-01

Results Overview

baseline PAI-1 levels prior to drug administration

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-02-01

Participant Flow

1 participant withdrew prior to randomization

Participant milestones

Measure	Eplerenone: Morning Administration Then Evening 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: Evening Administration Then Morning 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 Study STARTED	9	11
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diurnal Variation of Plasminogen Activator Inhibitor-1

Baseline characteristics by cohort

Measure	Eplerenone: Morning Administration Then Evening n=9 Participants 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: Evening Administration Then Morning n=11 Participants 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 n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

baseline PAI-1 levels prior to drug administration

Outcome measures

Measure	Eplerenone: Morning Administration Then Evening n=9 Participants 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: Evening Administration Then Morning n=11 Participants 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
Plasminogen Activator Inhibitor-1 (PAI-1) Levels	41.5 ng/ml Standard Deviation 17.9	42.9 ng/ml Standard Deviation 10.5

PRIMARY outcome

Timeframe: after 6 weeks on Eplerenone

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.

Outcome measures

Measure	Eplerenone: Morning Administration Then Evening n=20 Participants 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: Evening Administration Then Morning n=20 Participants 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
Plasminogen Activator Inhibitor-1 (PAI-1) Levels	39.9 ng/ml Standard Error 4.0	40.4 ng/ml Standard Error 3.8

Adverse Events

Eplerenone: Morning Administration Then Evening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Eplerenone: Evening Administration Then Morning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Muldowney

Vanderbilt University Medical Center

Phone: 615-936-1720

Email: james.muldowney@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place