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

Hyperlipidemias Clinical Trial

Official title:

Effects of Fenofibrate 160mg to 54mg Conversion on Triglyceride Levels in Patients on Statin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280604
• Other study ID #: KPGA-10KMani-01
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: June 4, 2015
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: June 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Drug:
• Fenofibrate 54mg
Subjects will receive fenofibrate 54mg daily.

Locations

Country	Name	City	State
United States	Kaiser Permanente of Georgia	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglyceride Levels	Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.	6-10 weeks	No
Secondary	Low-density Lipoprotein (LDL)	LDL levels will be assessed in study participants 6-10 weeks after entry into study.	6-10 weeks	No
Secondary	High-density Lipoprotein,(HDL)	HDL levels will be assessed in study participants 6-10 weeks after entry into study.	6-10 weeks	No
Secondary	Alanine Aminotransferase(ALT)	ALT levels will be assessed in study participants 6-10 weeks after entry into study.	6-10 weeks	No
Secondary	Aspartate Aminotransferase (AST)	AST levels will be assessed in study participants 6-10 weeks after entry into study.	6-10 weeks	No
Secondary	Serum Creatinine(SCr)	SCr levels will be assessed in study participants 6-10 weeks after entry into study.	6-10 weeks	No