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

This study has been completed.
Sponsor:
Information provided by:
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00504829
First received: July 18, 2007
Last updated: April 11, 2008
Last verified: April 2008
History of Changes

July 18, 2007
April 11, 2008
July 2007
February 2008   (final data collection date for primary outcome measure)
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. [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00504829 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
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

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

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Dyslipidemia
  • Drug: LCP-AtorFen
    anti-dyslipidemia
  • Drug: atorvastatin
    anti-dyslipidemia
  • Drug: fenofibrate
    anti-dyslipidemia
  • Experimental: 1
    LCP-AtorFen
    Intervention: Drug: LCP-AtorFen
  • Active Comparator: 2
    atorvastatin
    Intervention: Drug: atorvastatin
  • Active Comparator: 3
    fenofibrate
    Intervention: Drug: fenofibrate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00504829
LCP-AtorFen-2001
No
Not Provided
Veloxis Pharmaceuticals
Not Provided
Principal Investigator: Jeff Geohas, MD Radiant Research
Study Director: Dennis McCluskey, MD Radiant Research
Study Director: Harry Geisberg, MD Radiant Research
Study Director: Chivers Woodruff, Jr, MD Radiant Research
Study Director: Michael Noss, MD Radiant Research
Study Director: Michele Reynolds, MD Radiant Research
Study Director: James Zavoral, MD Radiant Research
Study Director: Randall Severance, MD Radiant Research
Study Director: Stephen Halpern, MD Radiant Research
Study Director: Linda Murray, MD Radiant Research
Study Director: Wayne Larson, MD Radiant Research
Study Director: Timothy Howards, MD Medical Affiliated Research Center, Inc.
Study Director: Cynthia Strout, MD Coastal Carolina Research Center
Study Director: Mark Kipnes, MD Diabetes and Glandular Research Center, Inc.
Veloxis Pharmaceuticals
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP