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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300430
• Other study ID #: M05-758
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2006
• Last updated: June 3, 2009
• Start date: September 2006

Study information

• Verified date: June 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1911
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Dyslipidemia
• Dyslipidemias
• Mixed Dyslipidemia
• Myocardial Ischemia

Intervention

Drug:
• ABT-335 and rosuvastatin calcium
ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks
• ABT-335 and atorvastatin calcium
ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks
• ABT-335 and simvastatin
ABT-335 135 mg plus simvastatin daily, 52 weeks

Locations

Country	Name	City	State
United States	Global Medical Information	North Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-Label Study		Baseline to Week 52 of the open-label study	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No