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Sponsored by: |
LifeCycle Pharma A/S |
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Information provided by: | LifeCycle Pharma A/S |
ClinicalTrials.gov Identifier: | NCT00504829 |
The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.
Condition | Intervention | Phase |
---|---|---|
Dyslipidemia |
Drug: LCP-AtorFen Drug: atorvastatin Drug: fenofibrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 220 |
Study Start Date: | July 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
LCP-AtorFen
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Drug: LCP-AtorFen
anti-dyslipidemia
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2: Active Comparator
atorvastatin
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Drug: atorvastatin
anti-dyslipidemia
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3: Active Comparator
fenofibrate
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Drug: fenofibrate
anti-dyslipidemia
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Radiant Research, 515 N State Street, Suite 2700 | |
Chicago, Illinois, United States, 60610 |
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: | 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. |
Study ID Numbers: | LCP-AtorFen-2001 |
Study First Received: | July 18, 2007 |
Last Updated: | April 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00504829 History of Changes |
Health Authority: | United States: Food and Drug Administration |
LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol |
LDL cholesterol Atorvastatin Fenofibrate |
Antimetabolites Metabolic Diseases Antilipemic Agents Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Procetofen Metabolic Disorder Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Procetofen Pharmacologic Actions Therapeutic Uses Dyslipidemias Atorvastatin Lipid Metabolism Disorders |