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Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LCP-AtorFen

atorvastatin

fenofibrate

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:

A diagnosis of dyslipidemia (non-HDL-C >130 mg/dL and Triglycerides > or equal to 150 mg/dL and < or equal to 500 mg/dL).
Subject may be currently on a statin or other lipid-lowering therapy but must be willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant, ezetimibe, or >1000 mg of fish oil per day.
Other inclusion criteria might apply

Exclusion Criteria:

TGs > 500 mg/dL.
History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior.
Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.
Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy.
Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia.
History of pancreatitis.
Known allergy or sensitivity to statins or fibrates.
Poorly controlled hypertension.
Other exclusion criteria might apply.

Sites / Locations

Radiant Research, 515 N State Street, Suite 2700

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

LCP-AtorFen

atorvastatin

fenofibrate

Arm Description

LCP-AtorFen 40/100mg fixed-dose combination tablet of 40mg atorvastatin and 145mg fenofibrate for treatment of mixed dyslipidemia

atorvastatin 40mg tablet (Lipitor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia

fenofibrate 145mg tablet (Tricor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia

Outcomes

Primary Outcome Measures

Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy

Mean percent change from baseline to end-of-treatment (12 weeks) for non-HDL cholesterol and triglycerides and the mean percent change from baseline to end-of-treatment for HDL cholesterol for AtorFen 40/100mg fixed-dose combination tablet versus atorvastatin 40mg tablet.

Secondary Outcome Measures

Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy

Mean percent changes from baseline (Visit 3, Week 0) to end-of-treatment (Visit 6; Week 12) in non-HDL, HDL and LDL cholesterol by LCP-AtorFen versus fenofibrate monotherapy

Full Information

NCT ID

NCT00504829

First Posted

July 18, 2007

Last Updated

February 4, 2020

Sponsor

Veloxis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00504829

Brief Title

Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia

Official Title

A 12-Week, Multi-Center, Double-Blind, Randomized, Parallel-Group Study, Followed by a 12 Month Extension Study, of the Efficacy and Safety of LCP-AtorFen in Subjects With Dyslipidemia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

July 2008 (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 efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.

Detailed Description

This is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label follow-up to evaluate the safety and efficacy of LCP-AtorFen (the combination of atorvastatin and fenofibrate) in the treatment of hyperlipidemia. After a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to either LCP-AtorFen, atorvastatin or fenofibrate for 12 weeks. After the completion of the 12-week phase, all eligible patients will be offered to receive open-label LCP-AtorFen for another 52 weeks.

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

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LCP-AtorFen

Arm Type

Experimental

Arm Description

LCP-AtorFen 40/100mg fixed-dose combination tablet of 40mg atorvastatin and 145mg fenofibrate for treatment of mixed dyslipidemia

Arm Title

atorvastatin

Arm Type

Active Comparator

Arm Description

atorvastatin 40mg tablet (Lipitor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia

Arm Title

fenofibrate

Arm Type

Active Comparator

Arm Description

fenofibrate 145mg tablet (Tricor), as an adjunct to diet and exercise for treatment of mixed dyslipidemia

Intervention Type

Drug

Intervention Name(s)

LCP-AtorFen

Intervention Description

40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia

Intervention Type

Drug

Intervention Name(s)

atorvastatin

Other Intervention Name(s)

Lipitor

Intervention Description

dyslipidemia and mixed dyslipidemia

Intervention Type

Drug

Intervention Name(s)

fenofibrate

Other Intervention Name(s)

Tricor

Intervention Description

dyslipidemia and mixed dyslipidemia

Primary Outcome Measure Information:

Title

Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy

Description

Time Frame

baseline(randomization) to 12 weeks

Secondary Outcome Measure Information:

Title

Percent Changes From Baseline to End-of-treatment in Non-HDL, HDL and LDL Cholesterol by LCP-AtorFen Versus Fenofibrate Monotherapy

Description

Mean percent changes from baseline (Visit 3, Week 0) to end-of-treatment (Visit 6; Week 12) in non-HDL, HDL and LDL cholesterol by LCP-AtorFen versus fenofibrate monotherapy

Time Frame

baseline (week 0) to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A diagnosis of dyslipidemia (non-HDL-C >130 mg/dL and Triglycerides > or equal to 150 mg/dL and < or equal to 500 mg/dL). Subject may be currently on a statin or other lipid-lowering therapy but must be willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant, ezetimibe, or >1000 mg of fish oil per day. Other inclusion criteria might apply Exclusion Criteria: TGs > 500 mg/dL. History of coronary heart disease (CHD), transient ischemic attacks, stroke or revascularization procedure in the six months prior. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months. Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy. Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial dysbetalipoproteinemia. History of pancreatitis. Known allergy or sensitivity to statins or fibrates. Poorly controlled hypertension. Other exclusion criteria might apply.

Overall Study Officials: