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

NCT00664859 | Completed Phase 2 Results

• 1 other identifier: LCP-AtorFen-2001-1X
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Dyslipidemia

Keywords

LCP-AtorFen; Non-HDL cholesterol; Triglycerides; HDL cholesterol; LDL cholesterol; Atorvastatin; Fenofibrate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment

  52 weeks from DB baseline and 40 weeks from OL baseline

Study Arms (1)

Single

EXPERIMENTAL

Open-label LCP-AtorFen

Drug: LCP-AtorFen

Interventions

LCP-AtorFen DRUG

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.

Also known as: atorvastatin and fenofibrate combination therapy

Single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Veloxis Pharmaceuticals: lead

Study Sites (1)

Radiant Research, 515 N State St, Suite 2700

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Director, Regulatory Affairs
• Organization: Veloxis Pharmaceuticals, Inc.

bbu@veloxis.com

919-591-3090

Study Officials

• Jeff Geohas, MD

  Radiant Research

  PRINCIPAL INVESTIGATOR

• 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.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: October 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Locations

US (1)