Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia

Phase 2

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: LCP-AtorFen; Drug: atorvastatin; Drug: fenofibrate

• Registration Number: NCT00504829
• Lead Sponsor: Veloxis Pharmaceuticals

Brief Summary

The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.

Detailed Description

This is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of LCP-AtorFen (the combination of atorvastatin and fenofibrate) in the treatment of hyperlipidemia.

After a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to either LCP-AtorFen, atorvastatin or fenofibrate for 12 weeks. After the completion of the 12-week phase, all eligible patients will be offered to receive open-label LCP-AtorFen for another 52 weeks.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-18
• Study First Submitted QC: 2007-07-18
• Study First Posted: 2007-07-20
• Primary Completion: 2008-02
• Study Completion: 2008-07
• Results First Submitted: 2014-12-18
• Results First Submitted QC: 2020-01-24
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Results First Posted: 2020-02-05
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. A diagnosis of dyslipidemia (non-HDL-C >130 mg/dL and Triglycerides > or equal to 150 mg/dL and < or equal to 500 mg/dL).
2. Subject may be currently on a statin or other lipid-lowering therapy but must be willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant, ezetimibe, or >1000 mg of fish oil per day.
3. Other inclusion criteria might apply

Exclusion Criteria

1. TGs > 500 mg/dL.
2. History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior.
3. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.
4. Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy.
5. Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia.
6. History of pancreatitis.
7. Known allergy or sensitivity to statins or fibrates.
8. Poorly controlled hypertension.
9. Other exclusion criteria might apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCP-AtorFen	LCP-AtorFen	LCP-AtorFen 40/100mg fixed-dose combination tablet of 40mg atorvastatin and 145mg fenofibrate for treatment of mixed dyslipidemia
atorvastatin	atorvastatin	atorvastatin 40mg tablet (Lipitor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia
fenofibrate	fenofibrate	fenofibrate 145mg tablet (Tricor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia

Primary Outcome Measures

Name	Time	Method
Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy	baseline(randomization) to 12 weeks	Mean percent change from baseline to end-of-treatment (12 weeks) for non-HDL cholesterol and triglycerides and the mean percent change from baseline to end-of-treatment for HDL cholesterol for AtorFen 40/100mg fixed-dose combination tablet versus atorvastatin 40mg tablet.

Secondary Outcome Measures

Name	Time	Method
Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy	baseline (week 0) to 12 weeks	Mean percent changes from baseline (Visit 3, Week 0) to end-of-treatment (Visit 6; Week 12) in non-HDL, HDL and LDL cholesterol by LCP-AtorFen versus fenofibrate monotherapy

Trial Locations

Locations (1)

Radiant Research, 515 N State Street, Suite 2700; 🇺🇸 Chicago, Illinois, United States