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

NCT00664859 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-03-24

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Jeff Geohas, MD · Radiant Research

  • Dennis McCluskey, MD · Radiant Resaerch

  • Harry Geisberg, MD · Radiant Research

  • Chivers Woodruff, Jr, MD · Radiant Research

  • Michael Noss, MD · Radiant Research

  • Michele Reynolds, MD · Radiant Research

  • James Zavoral, MD · Radiant Research

  • Randall Severance, MD · Radiant Research

  • Stephen Halpern, MD · Radiant Research

  • Linda Murray, MD · Radiant Research

  • Eduardo Cuevas, MD · Radiant Research

  • Cynthia Strout, MD · Coastal Carolina Research

  • Mark Kipnes, MD · Diabetes and Glandular Research Center, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664859 on ClinicalTrials.gov