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

Sponsor:	LifeCycle Pharma A/S
Information provided by:	LifeCycle Pharma A/S
ClinicalTrials.gov Identifier:	NCT00504829

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Procetofen Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by LifeCycle Pharma A/S:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

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	Drug: LCP-AtorFen anti-dyslipidemia
2: Active Comparator atorvastatin	Drug: atorvastatin anti-dyslipidemia
3: Active Comparator fenofibrate	Drug: fenofibrate anti-dyslipidemia

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Other inclusion criteria might apply

Exclusion Criteria:

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.
Other exclusion criteria might apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504829

Locations

United States, Illinois
Radiant Research, 515 N State Street, Suite 2700
Chicago, Illinois, United States, 60610

Sponsors and Collaborators

LifeCycle Pharma A/S

Investigators

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.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by LifeCycle Pharma A/S:

LCP-AtorFen
Non-HDL cholesterol
Triglycerides
HDL cholesterol

LDL cholesterol
Atorvastatin
Fenofibrate

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010