Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.

Phase 3

Completed

• Conditions: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
• Interventions: Drug: ABT-335 and simvastatin; Drug: ABT-335 and rosuvastatin calcium; Drug: ABT-335 and atorvastatin calcium

• Registration Number: NCT00300430
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-09
• Study Start: 2006-09
• Primary Completion: 2008-03
• Results First Submitted: 2009-03-10
• Status Verified: 2009-06
• Results First Submitted QC: 2009-06-03
• Last Update Submitted: 2009-06-03
• Results First Posted: 2009-07-23
• Last Update Posted: 2009-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1911

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	ABT-335 and simvastatin	40 mg drug and ABT-335
A	ABT-335 and rosuvastatin calcium	20 mg drug and ABT-335
B	ABT-335 and atorvastatin calcium	40 mg drug and ABT 335

Primary Outcome Measures

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

Name	Time	Method
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

Trial Locations

Locations (1)

Global Medical Information; 🇺🇸 North Chicago, Illinois, United States