NCT00872599

Brief Summary

The hypothesis is to test to see if the drug fenofibrate will increase important chemicals in the body and specifically in the kidney, help to rid the body of salt by the kidneys, decrease blood pressure and improve insulin sensitivity during high-salt intake in individuals with hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Sep 2009

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 20, 2013

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

2.3 years

First QC Date

March 26, 2009

Results QC Date

February 26, 2013

Last Update Submit

June 19, 2013

Conditions

Hypertension

Keywords

HypertensionPhenotypingHigh Salt intakefrequently sampled IV glucose tolerance test(FSIVGTT)fenofibrateepoxyeicosatrienoic acidshydroxyeicosatetraenoic acidsdihydroxyeicosatrienoic acidPPAR Alpha AgonistCYP Monooxygenase Activity

Outcome Measures

Primary Outcomes (1)

  • Change in Blood Pressure During High Salt Intake and Fenofibrate Treatment Compared to High Salt Intake and Placebo Treatment

    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.

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

Secondary Outcomes (1)

  • HDL-cholesterol Measured During High Salt Fenofibrate in Salt-resistant and Salt-sensitive Hypertension

    Measured on day 6 of high salt intake and fenofibrate treatment

Study Arms (2)

Placebo, then fenofibrate

PLACEBO COMPARATOR

Randomized study of fenofibrate versus placebo during high salt diet

Drug: fenofibrateDrug: Placebo

Fenofibrate, then placebo

PLACEBO COMPARATOR

Randomized study of fenofibrate versus placebo during high salt intake.

Drug: fenofibrateDrug: Placebo

Interventions

fenofibrateDRUG

Subjects will be randomized to receive either fenofibrate 160 mg/day or matching placebo for five days by mouth.

Also known as: Tricor
Fenofibrate, then placeboPlacebo, then fenofibrate
PlaceboDRUG

Subjects will be randomized to receive placebo or fenofibrate for five days by mouth

Fenofibrate, then placeboPlacebo, then fenofibrate

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory subjects, 18-70 years of age, inclusive
  • For female subjects, the following conditions must be met Postmenopausal status for at least 1 year, or Status post surgical sterilization, or If of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day

You may not qualify if:

  • Secondary causes of hypertension
  • Diabetes type 1 or type 2 as defined by a fasting glucose of 126 mg/dl or greater or the use of anti-diabetic medication
  • Use of hormone replacement therapy
  • Statin or fibrate therapy
  • A seated systolic blood pressure(SBP) greater than 179 mmHg or a seated diastolic blood pressure(DBP) greater than 110 mmHg
  • Pregnancy
  • Breast-feeding
  • Cardiovascular disease such as history of myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure, (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
  • Treatment with anticoagulants
  • History of serious neurologic diseases such as cerebral hemorrhage,stroke, or transient ischemic attack
  • History or presence of immunological or hematological disorders
  • Diagnosis of asthma
  • Clinically significant gastrointestinal impairment that could interfere with drug absorption
  • Impaired hepatic function (aspartate aminotransferase \[AST\] and or alanine aminotransferase \[ALT\] \> 2.0 x upper range)
  • Known preexisting gallbladder disease
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • Gilbert K, Nian H, Yu C, Luther JM, Brown NJ. Fenofibrate lowers blood pressure in salt-sensitive but not salt-resistant hypertension. J Hypertens. 2013 Apr;31(4):820-9. doi: 10.1097/HJH.0b013e32835e8227.

    PMID: 23385647RESULT

  • Ramirez CE, Shuey MM, Milne GL, Gilbert K, Hui N, Yu C, Luther JM, Brown NJ. Arg287Gln variant of EPHX2 and epoxyeicosatrienoic acids are associated with insulin sensitivity in humans. Prostaglandins Other Lipid Mediat. 2014 Oct;113-115:38-44. doi: 10.1016/j.prostaglandins.2014.08.001. Epub 2014 Aug 28.

    PMID: 25173047DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Results Point of Contact

Title
Nancy J. Brown, M.D.
Organization
Vanderbilt University
nancy.j.brown@vanderbilt.edu
615-343-8701

Study Officials

  • Nancy J Brown, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 31, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 28, 2013

Results First Posted

June 20, 2013

Record last verified: 2013-06

Locations

US(1)