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

NCT01280604 | Completed Results DMC

• 1 other identifier: KPGA-10KMani-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (1)

• Triglyceride Levels

  Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.

  6-10 weeks

Secondary Outcomes (5)

• Low-density Lipoprotein (LDL)

  6-10 weeks

• High-density Lipoprotein,(HDL)

  6-10 weeks

• Alanine Aminotransferase(ALT)

  6-10 weeks

• Aspartate Aminotransferase (AST)

  6-10 weeks

• Serum Creatinine(SCr)

  6-10 weeks

Study Arms (2)

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.

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).

Interventions

Fenofibrate 54mg DRUG

Subjects will receive fenofibrate 54mg daily.

Intervention 'Fenofibrate 54mg'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente of Georgia

Atlanta, Georgia, 30305, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Results Point of Contact

• Title: Kendra Manigault, PharmD, BCPS, BCACP, CDE
• Organization: Mercer University/ Kaiser Permanente

manigault_kr@mercer.edu

678-547-6216

Study Officials

• Kendra Manigault, PharmD

  Pharmacy Resident

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 21, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-06

Locations

US (1)