Clinical trial NCT00504829: Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
Official title: A 12-Week, Multi-Center, Double-Blind, Randomized, Parallel-Group Study, Followed by a 12 Month Extension Study, of the Efficacy and Safety of LCP-AtorFen in Subjects With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Keywords: LCP-AtorFen
Non-HDL cholesterol
Triglycerides
HDL cholesterol
LDL cholesterol
Atorvastatin
Fenofibrate
Lead sponsor: Veloxis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy
timeFrame: baseline(randomization) to 12 weeks
Secondary outcomes:
measure: Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy
timeFrame: baseline (week 0) to 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Radiant Research, 515 N State Street, Suite 2700
state: Illinois
Study officials:
affiliation: Radiant Research
name: Jeff Geohas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research
name: Dennis McCluskey, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Harry Geisberg, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Chivers Woodruff, Jr, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Michael Noss, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Michele Reynolds, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: James Zavoral, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Randall Severance, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Stephen Halpern, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Linda Murray, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Wayne Larson, MD
role: STUDY_DIRECTOR
affiliation: Medical Affiliated Research Center, Inc.
name: Timothy Howards, MD
role: STUDY_DIRECTOR
affiliation: Coastal Carolina Research Center
name: Cynthia Strout, MD
role: STUDY_DIRECTOR
affiliation: Diabetes and Glandular Research Center, Inc.
name: Mark Kipnes, MD
role: STUDY_DIRECTOR
References:
citation: Davidson MH, Rooney MW, Drucker J, Eugene Griffin H, Oosman S, Beckert M; LCP-AtorFen Investigators. Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study. Clin Ther. 2009 Dec;31(12):2824-38. doi: 10.1016/j.clinthera.2009.12.007.