Trial Outcomes & Findings for The Effect of a Peroxisome Proliferator-activated Receptor (PPAR) Alpha Agonist on Cytochrome P450 (CYP) Monooxygenase Activity in Humans (NCT NCT00872599)

Last Updated: 2013-06-28

Results Overview

Difference in blood pressure (mean arterial pressure) measured on the last day of high salt intake and fenofibrate treatment minus blood pressure (mean arterial pressure) measured during high salt intake and placebo treatment in participants classified as being salt-sensitive versus salt-resistant. Participants were classified as salt-sensitive if the average study day mean arterial pressure (MAP) was at least 5 mmHg higher during the high salt placebo arm than during low salt intake.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

pressure measured on day 6 of high salt fenofibrate minus pressure measured on day 6 of high salt placebo

Results posted on

2013-06-28

Participant Flow

After providing informed consent, subjects underwent a history and physical examination, screening electrocardiogram and laboratory assessment. Subjects were excluded if they did not meet inclusion and exclusion criteria.

All anti-hypertensive medications were discontinued for 3 weeks. Participants who met blood pressure safety criteria were discontinued. Remaining participants underwent a 6-day low salt diet period and study day prior to randomization. Thirty-three of 75 enrolled met inclusion criteria, and were not withdrawn for high blood pressure during washout.

Participant milestones

Participant milestones
Measure	Placebo, Then Fenofibrate Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received matching placebo. During the second they received fenofibrate 160mg/d.	Fenofibrate, Then Placebo Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received fenofibrate 160mg/d. During the second they received matching placebo.
First Washout Period After Low Salt STARTED	16	17
First Washout Period After Low Salt COMPLETED	16	17
First Washout Period After Low Salt NOT COMPLETED	0	0
First Drug During High Salt Intake STARTED	16	17
First Drug During High Salt Intake COMPLETED	16	17
First Drug During High Salt Intake NOT COMPLETED	0	0
Second Washout Period STARTED	16	17
Second Washout Period COMPLETED	15	16
Second Washout Period NOT COMPLETED	1	1
Second Drug During High Salt Intake STARTED	15	16
Second Drug During High Salt Intake COMPLETED	15	16
Second Drug During High Salt Intake NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo, Then Fenofibrate Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received matching placebo. During the second they received fenofibrate 160mg/d.	Fenofibrate, Then Placebo Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received fenofibrate 160mg/d. During the second they received matching placebo.
Second Washout Period Adverse Event	1	1

Baseline Characteristics

The Effect of a Peroxisome Proliferator-activated Receptor (PPAR) Alpha Agonist on Cytochrome P450 (CYP) Monooxygenase Activity in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=33 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	43.4 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: pressure measured on day 6 of high salt fenofibrate minus pressure measured on day 6 of high salt placebo

Population: All subjects who completed entire protocol

Outcome measures

Outcome measures
Measure	Salt-resistant Hypertension n=17 Participants Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake	Salt-sensitive Hypertension n=14 Participants Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
Change in Blood Pressure During High Salt Intake and Fenofibrate Treatment Compared to High Salt Intake and Placebo Treatment	2.0 mm Hg Standard Deviation 7.1	-3.4 mm Hg Standard Deviation 6.5

SECONDARY outcome

Timeframe: Measured on day 6 of high salt intake and fenofibrate treatment

Population: All subjects who completed the protocol

HDL-cholesterol concentration measured on the last day of fenofibrate treatment in salt-resistant and salt-sensitive hypertensive patients

Outcome measures

Outcome measures
Measure	Salt-resistant Hypertension n=17 Participants Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake	Salt-sensitive Hypertension n=14 Participants Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
HDL-cholesterol Measured During High Salt Fenofibrate in Salt-resistant and Salt-sensitive Hypertension	54.1 mg/dL Standard Deviation 20	52.1 mg/dL Standard Deviation 15.8

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Fenofibrate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=33 participants at risk	Fenofibrate n=33 participants at risk
Injury, poisoning and procedural complications IV infiltration or bruising	6.1% 2/33 • Number of events 2	6.1% 2/33 • Number of events 2
Vascular disorders High blood pressure during washout phase	3.0% 1/33 • Number of events 1	3.0% 1/33 • Number of events 1

Additional Information

Nancy J. Brown, M.D.

Vanderbilt University

Phone: 615-343-8701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place