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

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LCP-AtorFen

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring LCP-AtorFen, Non-HDL cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol, Atorvastatin, Fenofibrate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.
Other exclusion conditions might apply.

Sites / Locations

Radiant Research, 515 N State St, Suite 2700

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single

Arm Description

Open-label LCP-AtorFen

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

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)

Full Information

NCT ID

NCT00664859

First Posted

April 21, 2008

Last Updated

March 2, 2020

Sponsor

Veloxis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00664859

Brief Title

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

Official Title

A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Veloxis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single

Arm Type

Experimental

Arm Description

Open-label LCP-AtorFen

Intervention Type

Drug

Intervention Name(s)

LCP-AtorFen

Other Intervention Name(s)

atorvastatin and fenofibrate combination therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment

Description

Time Frame

52 weeks from DB baseline and 40 weeks from OL baseline

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

52 weeks from DB baseline and 40 weeks from OL baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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. Other exclusion conditions might apply.

Overall Study Officials: