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Sponsored by: |
LifeCycle Pharma A/S |
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Information provided by: | LifeCycle Pharma A/S |
ClinicalTrials.gov Identifier: | NCT00664859 |
The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia
Condition | Intervention | Phase |
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Dyslipidemia |
Drug: LCP-AtorFen |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia |
Estimated Enrollment: | 220 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single: Experimental
Open-label LCP-AtorFen
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Drug: LCP-AtorFen
All subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals.
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POPULATION:
Subjects with mixed dyslipidemia (non-HDL cholesterol > 130 mg/dL and TG ≥ 150 mg/dL and ≤ 500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and elected to enter the open-label extension study.
STUDY DESIGN AND DURATION:
This is a 52-week, open-label, single-treatment arm with 8 visits (Weeks 0, 4, 8, 12, 24, 36, 48 and 52). A maximum of approximately 200 subjects will enter this open-label safety and efficacy extension study from the LCP AtorFen-2001 double-blind study. All subjects enrolled in this study will receive open-label LCP-AtorFen combination therapy. Visit 1 of the extension study corresponds to the last visit of the double-blind study (Visit 6 or Week 12).
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 St, Suite 2700 | |
Chicago, Illinois, United States, 60610 |
Principal Investigator: | Jeff Geohas, MD | Radiant Research |
Study Director: | Dennis McCluskey, MD | Radiant Resaerch |
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: | Eduardo Cuevas, MD | Radiant Research |
Study Director: | Cynthia Strout, MD | Coastal Carolina Research |
Study Director: | Mark Kipnes, MD | Diabetes and Glandular Research Center, Inc. |
Responsible Party: | LifeCycle Pharma A/S ( LifeCycle Pharma A/S ) |
Study ID Numbers: | LCP-AtorFen-2001-1X |
Study First Received: | April 21, 2008 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00664859 |
Health Authority: | United States: Food and Drug Administration |
LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol |
LDL cholesterol Atorvastatin Fenofibrate |
Metabolic Diseases Metabolic disorder Procetofen |
Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |