12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: LCP-AtorFen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has successfully completed the double-blind study (LCP-AtorFen-2001; NCT00504829). Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the study by voluntarily signing and dating an informed consent form in accordance with Good Clinical Practice (GCP). Exclusion Criteria: Study drug compliance <70% in the double-blind study. Any ongoing serious adverse event, or any ongoing non-serious moderate or severe adverse event from the double-blind study that is rated as possibly, probably or definitely related to study drug. Resting blood pressure >/=160 mm Hg systolic and/or >/=100 mm Hg diastolic. Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis. Any clinically significant change in physical exam or electrocardiogram from Visit 2 to Visit 6 of the double-blind study. Any clinically significant change from Visit 1 to Visit 6 of the double-blind study in medical history including, but not limited to: a diagnosis of insulin-dependent diabetes mellitus (DM); poorly controlled DM; poorly controlled hypertension; significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease; cancer (except non-melanoma skin cancer); and epilepsy. Unwilling to abstain from medications, supplements, ingredients and herbal therapies that were excluded in the double-blind study and continue to be excluded in the open-label study. Women who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential (not surgically sterilized between menarche and menopause) who are not using a medically approved method of contraception. Other exclusion conditions might apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br>Open-label LCP-AtorFen | Drug: LCP-AtorFen<br>* 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.<br>* Other names: atorvastatin and fenofibrate combination therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment | Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52) | 52 weeks from DB baseline and 40 weeks from OL baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment | Mean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52) | 52 weeks from DB baseline and 40 weeks from OL baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LCP-AtorFen, Non-HDL cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol, Atorvastatin, Fenofibrate