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Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01280604
First received: January 19, 2011
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Hyperlipidemias
Drug: Fenofibrate 54mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Fenofibrate 160mg to 54mg Conversion on Triglyceride Levels in Patients on Statin Therapy

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Triglyceride Levels [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]
    Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.


Secondary Outcome Measures:
  • Low-density lipoprotein (LDL) [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]
    LDL levels will be assessed in study participants 6-10 weeks after entry into study.

  • High-density lipoprotein,(HDL) [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]
    HDL levels will be assessed in study participants 6-10 weeks after entry into study.

  • Alanine aminotransferase(ALT) [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]
    ALT levels will be assessed in study participants 6-10 weeks after entry into study.

  • Aspartate aminotransferase (AST) [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]
    AST levels will be assessed in study participants 6-10 weeks after entry into study.

  • Serum creatinine(SCr) [ Time Frame: 6-10 weeks ] [ Designated as safety issue: No ]
    SCr levels will be assessed in study participants 6-10 weeks after entry into study.


Enrollment: 66
Study Start Date: October 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Drug: Fenofibrate 54mg
Subjects will receive fenofibrate 54mg daily.
No Intervention: Control
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280604

Locations
United States, Georgia
Kaiser Permanente of Georgia
Atlanta, Georgia, United States, 30305
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Kendra Manigault, PharmD Pharmacy Resident
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01280604     History of Changes
Other Study ID Numbers: KPGA-10KMani-01
Study First Received: January 19, 2011
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014