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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00872599
First received: March 26, 2009
Last updated: June 19, 2013
Last verified: June 2013
Results First Received: February 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: fenofibrate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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 Thirty-three of 75 enrolled met inclusion criteria, and were not withdrawn for high blood pressure during washout.

Reporting Groups
  Description
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.

Participant Flow for 4 periods

Period 1:   First Washout Period After Low Salt
    Placebo, Then Fenofibrate     Fenofibrate, Then Placebo  
STARTED     16     17  
COMPLETED     16     17  
NOT COMPLETED     0     0  

Period 2:   First Drug During High Salt Intake
    Placebo, Then Fenofibrate     Fenofibrate, Then Placebo  
STARTED     16     17  
COMPLETED     16     17  
NOT COMPLETED     0     0  

Period 3:   Second Washout Period
    Placebo, Then Fenofibrate     Fenofibrate, Then Placebo  
STARTED     16     17  
COMPLETED     15     16  
NOT COMPLETED     1     1  
Adverse Event                 1                 1  

Period 4:   Second Drug During High Salt Intake
    Placebo, Then Fenofibrate     Fenofibrate, Then Placebo  
STARTED     15     16  
COMPLETED     15     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Total number who completed the screening and low salt diet and were randomized.

Reporting Groups
  Description
Study Group No text entered.

Baseline Measures
    Study Group  
Number of Participants  
[units: participants]
  33  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     33  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.4  ± 11.6  
Gender  
[units: participants]
 
Female     18  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Blood Pressure During High Salt Intake and Fenofibrate Treatment Compared to High Salt Intake and Placebo Treatment   [ Time Frame: pressure measured on day 6 of high salt fenofibrate minus pressure measured on day 6 of high salt placebo ]

2.  Secondary:   HDL-cholesterol Measured During High Salt Fenofibrate in Salt-resistant and Salt-sensitive Hypertension   [ Time Frame: Measured on day 6 of high salt intake and fenofibrate treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Nancy J. Brown, M.D.
Organization: Vanderbilt University
phone: 615-343-8701
e-mail: nancy.j.brown@vanderbilt.edu


Publications of Results:

Responsible Party: Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00872599     History of Changes
Other Study ID Numbers: PPAR Alpha Agonist, Grant# DK38226-21
Study First Received: March 26, 2009
Results First Received: February 26, 2013
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board