Clinical trial NCT00664859: 12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
Official title: A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dyslipidemia
Keywords: LCP-AtorFen
Non-HDL cholesterol
Triglycerides
HDL cholesterol
LDL cholesterol
Atorvastatin
Fenofibrate
Lead sponsor: Veloxis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
timeFrame: 52 weeks from DB baseline and 40 weeks from OL baseline
Secondary outcomes:
measure: Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
timeFrame: 52 weeks from DB baseline and 40 weeks from OL baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Radiant Research, 515 N State St, Suite 2700
state: Illinois
Study officials:
affiliation: Radiant Research
name: Jeff Geohas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Resaerch
name: Dennis McCluskey, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Harry Geisberg, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Chivers Woodruff, Jr, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Michael Noss, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Michele Reynolds, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: James Zavoral, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Randall Severance, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Stephen Halpern, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Linda Murray, MD
role: STUDY_DIRECTOR
affiliation: Radiant Research
name: Eduardo Cuevas, MD
role: STUDY_DIRECTOR
affiliation: Coastal Carolina Research
name: Cynthia Strout, MD
role: STUDY_DIRECTOR
affiliation: Diabetes and Glandular Research Center, Inc.
name: Mark Kipnes, MD
role: STUDY_DIRECTOR
References: