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

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ClinicalTrials.gov Identifier: NCT00664859
Recruitment Status : Completed
First Posted : April 23, 2008
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 21, 2008
First Posted Date  ICMJE April 23, 2008
Results First Submitted Date  ICMJE February 14, 2020
Results First Posted Date  ICMJE March 24, 2020
Last Update Posted Date March 24, 2020
Study Start Date  ICMJE October 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment [ Time Frame: 52 weeks from DB baseline and 40 weeks from OL baseline ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment [ Time Frame: 52 weeks from DB baseline and 40 weeks from OL baseline ]
Mean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia
Official Title  ICMJE A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dyslipidemia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Single
Open-label LCP-AtorFen
Intervention: Drug: LCP-AtorFen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2020)
140
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2008)
220
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00664859
Other Study ID Numbers  ICMJE LCP-AtorFen-2001-1X
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Veloxis Pharmaceuticals
Study Sponsor  ICMJE Veloxis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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.
PRS Account Veloxis Pharmaceuticals
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP