HealthyNCT00644592
LXRA Gene Polymorphisms and Response to Fenofibrate
A study testing Fenofibrate capsule daily for 4 weeks and Fenofibrate in people with Healthy, run by University of Florida at 1 site in United States.
Trial summary
This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fenofibrate capsule daily for 4 weeks and Fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below 54 mg/dl for women)
- Must be able to swallow tablets
Who cannot join
- Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic aneurysm, diabetes, or Framingham risk score above 20%
- Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse, history of unexplained muscle pain
- Current treatment with lipid lowering therapy, estrogens, androgens, progestins, thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled), antihistamines, or chronic anti-inflammatory drugs
- Current treatment with the following the interacting drugs: ursodeoxycholic acid, ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or cyclosporine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida College of Pharmacy, Center for Pharmacogenomics
Gainesville, Florida, 32610
About this study
This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.
Read the detailed description
This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.
- Conditions
- Healthy
- Being tested
- Fenofibrate capsule daily for 4 weeks, Fenofibrate
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate capsule daily for 4 weeksDrug
Placebo capsule daily for 4 weeks
FenofibrateDrug
160 mg/day orally for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1-Fenofibrate then Placebo | Active comparator | 4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo Receives: Drug: Fenofibrate capsule daily for 4 weeks; Drug: Fenofibrate |
| 2 Placebo then Fenofibrate | Active comparator | 4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally. Receives: Drug: Fenofibrate capsule daily for 4 weeks; Drug: Fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log(ENA-Period 2 End/ENA Period 1 End)
Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects.
Natural logs used
Measured: week 12 to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: supply issues with the formulation of fenofibrate that was used.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Responsible party
- Sponsor
- Investigators
- Issam Zineh, PharmD, Principal investigator, University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644592
- Sponsor's protocol ID
- 302-2007
- Status last verified
- May 2012
- First submitted
- 21 Mar 2008
- Last updated
- 1 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LXRA Gene Polymorphisms and Response to Fenofibrate
- ClinicalTrials.gov ID
- NCT00644592
- Acronym / sponsor ID
- 302-2007
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: supply issues with the formulation of fenofibrate that was used.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Study start
- Mar 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Posted 24 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.
Detailed description
This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Fenofibrate then Placebo | Active comparator | Drug: Fenofibrate capsule daily for 4 weeks, Drug: Fenofibrate4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo |
| 2 Placebo then Fenofibrate | Active comparator | Drug: Fenofibrate capsule daily for 4 weeks, Drug: Fenofibrate4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below 54 mg/dl for women)
- Must be able to swallow tablets
Key exclusion criteria (4 listed)
- Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic aneurysm, diabetes, or Framingham risk score above 20%
- Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse, history of unexplained muscle pain
- Current treatment with lipid lowering therapy, estrogens, androgens, progestins, thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled), antihistamines, or chronic anti-inflammatory drugs
- Current treatment with the following the interacting drugs: ursodeoxycholic acid, ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or cyclosporine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibrate capsule daily for 4 weeksPlacebo capsule daily for 4 weeks | Drug | 1-Fenofibrate then Placebo, 2 Placebo then Fenofibrate |
| Fenofibrate160 mg/day orally for 4 weeks | Drug | 1-Fenofibrate then Placebo, 2 Placebo then Fenofibrate |
Primary outcome
Log(ENA-Period 2 End/ENA Period 1 End)
Time frame: week 12 to week 4
Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects. Natural logs used
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issam Zineh, PharmD principal investigator
University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenofibrate capsule daily for 4 weeks and Fenofibrate in people with Healthy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Log(ENA-Period 2 End/ENA Period 1 End) (time frame: week 12 to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.