HyperlipidemiasNCT01280604
Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy
A study testing Fenofibrate 54mg in people with Hyperlipidemias, run by Kaiser Permanente at 1 site in United States.
Trial summary
The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Fenofibrate 54mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2013
- 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
- Adults 18 years of age or older
- Patients actively taking fenofibrate 160mg and statin therapy
- A fasting lipid panel within the past 9 months with most recent triglycerides levels less than 200mg/dL
- Primary care physician approves participation and fenofibrate conversion
Who cannot join
- Impaired renal function defined as creatine clearance ≤ 50ml/min
- Current enrollment in other studies or clinical trials
- Previous fenofibrate 54mg use
- A history of pancreatitis or known previous triglyceride levels >1000mg/dL
- Pregnancy
- Members with plan benefits that include a deductible for lab services at Kaiser Permanente
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente of Georgia
Atlanta, Georgia, 30305
About this study
Official title: Effects of Fenofibrate 160mg to 54mg Conversion on Triglyceride Levels in Patients on Statin Therapy
The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides.
Read the detailed description
Hypothesis: Study subjects receiving fenofibrate 54mg will maintain similar triglyceride levels as patients on 160mg of fenofibrate.
The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. Secondary objectives include evaluating effect of the dosage change on low-density lipoprotein (LDL), HDL, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr), and the potential cost savings associated with prescribing 54mg instead of 160mg. Electronic medical records will be used to identify subjects and gather data on demographics, comorbid conditions, and concomitant lipid lowering therapy. Subjects will be recruited for enrollment via telephone by the principal investigator (PI), co-principal investigators (Co-PIs), or provider referral after eligibility screening and approval from their primary care physician. Subjects must provide written informed consent and Health Insurance Privacy and Accountability Act (HIPAA) privacy rule authorization prior to participation in this study. Subjects will be randomized to either the intervention arm (conversion to 54mg of fenofibrate) or to the control arm (remain on 160mg of fenofibrate). Subjects in both study arms will have fasting lipid panels, ALT/AST, and SCr evaluated at baseline. All subjects will have repeat labs approximately 8 weeks after enrollment. All subjects will continue to receive standard care based on lipid values. The study period will begin approximately October 29, 2010 and run to June 30, 2011.
- Conditions
- Hyperlipidemias
- Being tested
- Fenofibrate 54mg
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate 54mgDrug
Subjects will receive fenofibrate 54mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 'Fenofibrate 54mg' | Experimental | Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks. Receives: Drug: Fenofibrate 54mg |
| Control 'Fenofibrate 160mg' | No intervention | Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride Levels
Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.
Measured: 6-10 weeks
Secondary outcomes (5)
Low-density Lipoprotein (LDL)
LDL levels will be assessed in study participants 6-10 weeks after entry into study.
Measured: 6-10 weeks
High-density Lipoprotein,(HDL)
HDL levels will be assessed in study participants 6-10 weeks after entry into study.
Measured: 6-10 weeks
Alanine Aminotransferase(ALT)
ALT levels will be assessed in study participants 6-10 weeks after entry into study.
Measured: 6-10 weeks
Aspartate Aminotransferase (AST)
AST levels will be assessed in study participants 6-10 weeks after entry into study.
Measured: 6-10 weeks
Serum Creatinine(SCr)
SCr levels will be assessed in study participants 6-10 weeks after entry into study.
Measured: 6-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2013
- Study completionJan 2013
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 HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kendra Manigault, PharmD, Principal investigator, Pharmacy Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280604
- Sponsor's protocol ID
- KPGA-10KMani-01
- Status last verified
- Jun 2015
- First submitted
- 19 Jan 2011
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fenofibrate 160mg to 54mg Conversion on Triglyceride Levels in Patients on Statin Therapy
- ClinicalTrials.gov ID
- NCT01280604
- Acronym / sponsor ID
- KPGA-10KMani-01
- Conditions
- Hyperlipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Posted 8 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides.
Detailed description
Hypothesis: Study subjects receiving fenofibrate 54mg will maintain similar triglyceride levels as patients on 160mg of fenofibrate.
The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. Secondary objectives include evaluating effect of the dosage change on low-density lipoprotein (LDL), HDL, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr), and the potential cost savings associated with prescribing 54mg instead of 160mg. Electronic medical records will be used to identify subjects and gather data on demographics, comorbid conditions, and concomitant lipid lowering therapy. Subjects will be recruited for enrollment via telephone by the principal investigator (PI), co-principal investigators (Co-PIs), or provider referral after eligibility screening and approval from their primary care physician. Subjects must provide written informed consent and Health Insurance Privacy and Accountability Act (HIPAA) privacy rule authorization prior to participation in this study. Subjects will be randomized to either the intervention arm (conversion to 54mg of fenofibrate) or to the control arm (remain on 160mg of fenofibrate). Subjects in both study arms will have fasting lipid panels, ALT/AST, and SCr evaluated at baseline. All subjects will have repeat labs approximately 8 weeks after enrollment. All subjects will continue to receive standard care based on lipid values. The study period will begin approximately October 29, 2010 and run to June 30, 2011.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention 'Fenofibrate 54mg' | Experimental | Drug: Fenofibrate 54mgSubjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks. |
| Control 'Fenofibrate 160mg' | No intervention | –Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18 years of age or older
- Patients actively taking fenofibrate 160mg and statin therapy
- A fasting lipid panel within the past 9 months with most recent triglycerides levels less than 200mg/dL
- Primary care physician approves participation and fenofibrate conversion
Key exclusion criteria (6 listed)
- Impaired renal function defined as creatine clearance ≤ 50ml/min
- Current enrollment in other studies or clinical trials
- Previous fenofibrate 54mg use
- A history of pancreatitis or known previous triglyceride levels >1000mg/dL
- Pregnancy
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 54mgSubjects will receive fenofibrate 54mg daily. | Drug | Intervention 'Fenofibrate 54mg' |
Primary outcome
Triglyceride Levels
Time frame: 6-10 weeks
Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.
5 secondary outcomes
Low-density Lipoprotein (LDL)
Time frame: 6-10 weeks
High-density Lipoprotein,(HDL)
Time frame: 6-10 weeks
Alanine Aminotransferase(ALT)
Time frame: 6-10 weeks
Aspartate Aminotransferase (AST)
Time frame: 6-10 weeks
Serum Creatinine(SCr)
Time frame: 6-10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- 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.
Kendra Manigault, PharmD principal investigator
Pharmacy Resident
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 54mg in people with Hyperlipidemias, run by Kaiser Permanente 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jun 2015. 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 8 Jun 2015). 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?
Triglyceride Levels (time frame: 6-10 weeks). 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 8 Jun 2015.