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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00664859
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):
Veloxis Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: LCP-AtorFen Phase 2 Phase 3

Detailed Description:


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.


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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia
Study Start Date : October 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

Arm Intervention/treatment
Experimental: Single
Open-label LCP-AtorFen
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.
Other Name: atorvastatin and fenofibrate combination therapy

Primary Outcome Measures :
  1. 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). [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00664859

United States, Illinois
Radiant Research, 515 N State St, Suite 2700
Chicago, Illinois, United States, 60610
Sponsors and Collaborators
Veloxis Pharmaceuticals
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: Veloxis Pharmaceuticals Identifier: NCT00664859     History of Changes
Other Study ID Numbers: LCP-AtorFen-2001-1X
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: October 2009

Keywords provided by Veloxis Pharmaceuticals:
Non-HDL cholesterol
HDL cholesterol
LDL cholesterol

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors