Trial Outcomes & Findings for Effect of a Fibrate and a Statin on Endothelial Dysfunction (NCT NCT00491400)

Results Overview

Endothelial function was assessed as brachial artery flow-mediated dilation (FMD) using ultrasound. FMD is calculated as the difference in brachial diameter during hyperemic flow and brachial diameter at baseline divided by brachial diameter at baseline and expressed as percent dilation.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

8 weeks

Results posted on

2012-10-24

Participant Flow

Patients meeting the entry criteria were recruited at Boston Medical Center.

101 patients were consented and underwent screening. 73 were excluded because testing demonstrated that they were ineligible. 28 Entered the study 9 withdrew from the study

Participant milestones

Participant milestones
Measure	Fenofibrate First Participants randomized to receive fenofibrate first and atorvastatin second	Atorvastatin First Participants randomized to receive atorvastatin first and fenofibrate second
Overall Study STARTED	15	13
Overall Study Started First Treatment	14	13
Overall Study Completed First Treatment	14	9
Overall Study Started Second Treatment	12	9
Overall Study Finished Second Treatment	10	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Fenofibrate First Participants randomized to receive fenofibrate first and atorvastatin second	Atorvastatin First Participants randomized to receive atorvastatin first and fenofibrate second
Overall Study Withdrawal by Subject	5	4

Baseline Characteristics

Effect of a Fibrate and a Statin on Endothelial Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fenofibrate First n=15 Participants Fenofibrate First and Atorvastatin Second	Atorvastatin First n=13 Participants Atorvastatin First and Fenofibrate Second	Total n=28 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	15 Participants n=5 Participants	13 Participants n=7 Participants	28 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	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	13 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The number of participants is too few for meaningful analysis.

Endothelial function was assessed as brachial artery flow-mediated dilation (FMD) using ultrasound. FMD is calculated as the difference in brachial diameter during hyperemic flow and brachial diameter at baseline divided by brachial diameter at baseline and expressed as percent dilation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: Enrollment was insufficient and there are too few subjects for meaningful analysis

Effect of the intervention on total cholesterol, HDL, and triglycerides

Outcome measures

Outcome data not reported

Adverse Events

Fenofibrate First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atorvastatin First

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

Joseph A. Vita, MD

Boston University

Phone: 617-638-8700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place