12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
Information source: LifeCycle Pharma A/S
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia
Intervention: LCP-AtorFen (Drug)
Phase: Phase 2/Phase 3
Status: Active, not recruiting
Sponsored by: LifeCycle Pharma A/S Official(s) and/or principal investigator(s):
Jeff Geohas, MD, Principal Investigator, Affiliation: Radiant Research
Dennis McCluskey, MD, Study Director, Affiliation: Radiant Resaerch
Harry Geisberg, MD, Study Director, Affiliation: Radiant Research
Chivers Woodruff, Jr, MD, Study Director, Affiliation: Radiant Research
Michael Noss, MD, Study Director, Affiliation: Radiant Research
Michele Reynolds, MD, Study Director, Affiliation: Radiant Research
James Zavoral, MD, Study Director, Affiliation: Radiant Research
Randall Severance, MD, Study Director, Affiliation: Radiant Research
Stephen Halpern, MD, Study Director, Affiliation: Radiant Research
Linda Murray, MD, Study Director, Affiliation: Radiant Research
Eduardo Cuevas, MD, Study Director, Affiliation: Radiant Research
Cynthia Strout, MD, Study Director, Affiliation: Coastal Carolina Research
Mark Kipnes, MD, Study Director, Affiliation: Diabetes and Glandular Research Center, Inc.
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
Clinical Details
Official title: A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The primary endpoints are the mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind baseline (Week 0) to end-of-treatment (Week 52), and from the open-label baseline (Visit 1) to Week 52 (Visit 8).
Secondary outcome: Number (percentage) of subjects at end-of-treatment (Visit 8; Week 52) who achieve the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) goal of non-HDL cholesterol of 30 mg/dL higher than the LDL cholesterol.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Radiant Research, 515 N State St, Suite 2700, Chicago, Illinois 60610, United States
Additional Information
Starting date: October 2007
Ending date: February 2009
Last updated: April 21, 2008
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