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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:
ClinicalTrials.gov Identifier:
NCT00872599
First Posted: March 31, 2009
Last Update Posted: June 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University
Results First Submitted: February 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, 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 Thirty-three of 75 enrolled met inclusion criteria, and were not withdrawn for high blood pressure during washout.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 
Overall Participants Analyzed 
[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


  Limitations and Caveats
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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.


  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.


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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00872599     History of Changes
Other Study ID Numbers: PPAR Alpha Agonist
Grant# DK38226-21
First Submitted: March 26, 2009
First Posted: March 31, 2009
Results First Submitted: February 26, 2013
Results First Posted: June 20, 2013
Last Update Posted: June 28, 2013