Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
This study has been completed.
Sponsor:
Veloxis Pharmaceuticals
Information provided by:
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00504829
First received: July 18, 2007
Last updated: April 11, 2008
Last verified: April 2008
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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:
Further study details as provided by Veloxis Pharmaceuticals:
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 |
|---|---|
|
Experimental: 1
LCP-AtorFen
|
Drug: LCP-AtorFen
anti-dyslipidemia
|
|
Active Comparator: 2
atorvastatin
|
Drug: atorvastatin
anti-dyslipidemia
|
|
Active Comparator: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504829
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
Veloxis Pharmaceuticals
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: | 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
No publications provided by Veloxis Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00504829 History of Changes |
| Other Study ID Numbers: | LCP-AtorFen-2001 |
| Study First Received: | July 18, 2007 |
| Last Updated: | April 11, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Veloxis Pharmaceuticals:
|
LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol |
LDL cholesterol Atorvastatin Fenofibrate |
Additional relevant MeSH terms:
|
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Fenofibrate Anticholesteremic Agents Antimetabolites |
Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015