Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
Information source: LifeCycle Pharma A/S
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia
Intervention: LCP-AtorFen (Drug); atorvastatin (Drug); fenofibrate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: LifeCycle Pharma A/S Official(s) and/or principal investigator(s):
Jeff Geohas, MD, Principal Investigator, Affiliation: Radiant Research
Dennis McCluskey, MD, Study Director, Affiliation: Radiant Research
Harry Geisberg, MD, Study Director, Affiliation: Radiant Research
Chivers Woodruff, Jr, MD, Study Director, Affiliation: Radiant Research
Michael Noss, MD, Study Director, Affiliation: Radiant Research
Michele Reynolds, MD, Study Director, Affiliation: Radiant Research
James Zavoral, MD, Study Director, Affiliation: Radiant Research
Randall Severance, MD, Study Director, Affiliation: Radiant Research
Stephen Halpern, MD, Study Director, Affiliation: Radiant Research
Stephen Halpern, MD, Study Director, Affiliation: Radiant Research
Linda Murray, MD, Study Director, Affiliation: Radiant Research
Wayne Larson, MD, Study Director, Affiliation: Radiant Research
Timothy Howards, MD, Study Director, Affiliation: Medical Affiliated Research Center, Inc.
Cynthia Strout, MD, Study Director, Affiliation: Coastal Carolina Research Center
Mark Kipnes, MD, Study Director, Affiliation: Diabetes and Glandular Research Center, Inc.
Summary
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a
combination of atorvastatin and fenofibrate.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary objectives of the study are to assess the non-HDL cholesterol and triglyceride lowering efficacy as well as the HDL cholesterol increasing efficacy of LCP AtorFen versus atorvastatin.
Secondary outcome: The secondary objectives of the study are to assess the non-HDL and LDL cholesterol lowering efficacy as well as the HDL cholesterol increasing efficacy of LCP-AtorFen versus 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Radiant Research, 515 N State Street, Suite 2700, Chicago, Illinois 60610, United States
Additional Information
Starting date: July 2007
Ending date: February 2008
Last updated: April 11, 2008
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