12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
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
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).
Inclusion Criteria:

 1. Subject has successfully completed the double-blind study (LCP-AtorFen-2001;
 NCT00504829).

 2. 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:

 1. Study drug compliance <70% in the double-blind study.

 2. 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.

 3. Resting blood pressure >/=160 mm Hg systolic and/or >/=100 mm Hg diastolic.

 4. Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of
 possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.

 5. Any clinically significant change in physical exam or electrocardiogram from Visit 2
 to Visit 6 of the double-blind study.

 6. 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.

 7. 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.

 8. 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.

 9. Other exclusion conditions might apply.