A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia

Abbott1 site in 1 country1,911 target enrollmentSeptember 2006

ConditionsDyslipidemia Coronary Heart Disease Mixed Dyslipidemia

InterventionsABT-335 and rosuvastatin calcium ABT-335 and atorvastatin calcium ABT-335 and simvastatin

DrugsABT-335 and rosuvastatin calcium ABT-335 and atorvastatin calcium ABT-335 and simvastatin

Overview

Phase: Phase 3
Intervention: ABT-335 and rosuvastatin calcium
Conditions: Dyslipidemia
Sponsor: Abbott
Enrollment: 1911
Locations: 1
Primary Endpoint: Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

March 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

Eligibility Criteria

Inclusion Criteria

•Adult male and female subjects who voluntarily sign the informed consent.
•Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.

Exclusion Criteria

•Subject is using or will use investigational medications, except as approved by Abbott.
•Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.

Arms & Interventions

A

20 mg drug and ABT-335

Intervention: ABT-335 and rosuvastatin calcium

B

40 mg drug and ABT 335

Intervention: ABT-335 and atorvastatin calcium

C

40 mg drug and ABT-335

Intervention: ABT-335 and simvastatin

Outcomes

Primary Outcomes

Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study

Time Frame: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy

Secondary Outcomes

Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study(Baseline to Week 52 in this open-label study)
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)