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
1 other identifier
interventional
220
1 country
1
Brief Summary
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 18, 2007
CompletedFirst Posted
Study publicly available on registry
July 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
February 5, 2020
CompletedFebruary 17, 2020
February 1, 2020
7 months
July 18, 2007
December 18, 2014
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy
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.
baseline(randomization) to 12 weeks
Secondary Outcomes (1)
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
Study Arms (3)
LCP-AtorFen
EXPERIMENTALLCP-AtorFen 40/100mg fixed-dose combination tablet of 40mg atorvastatin and 145mg fenofibrate for treatment of mixed dyslipidemia
atorvastatin
ACTIVE COMPARATORatorvastatin 40mg tablet (Lipitor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia
fenofibrate
ACTIVE COMPARATORfenofibrate 145mg tablet (Tricor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia
Interventions
40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- TGs \> 500 mg/dL.
- History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior.
- Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.
- Poorly controlled diabetes mellitus (glycosylated hemoglobin \>8.0% )or diabetes mellitus requiring insulin therapy.
- Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia.
- History of pancreatitis.
- Known allergy or sensitivity to statins or fibrates.
- Poorly controlled hypertension.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radiant Research, 515 N State Street, Suite 2700
Chicago, Illinois, 60610, United States
Related Publications (1)
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.
PMID: 20110022DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- H. Eugene Griffin, MS, DVM
- Organization
- Life Cycle Pharma
Study Officials
- 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.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 20, 2007
Study Start
July 1, 2007
Primary Completion
February 1, 2008
Study Completion
July 1, 2008
Last Updated
February 17, 2020
Results First Posted
February 5, 2020
Record last verified: 2020-02