A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

Phase 3

Completed

• Conditions: Mixed Dyslipidemia
• Interventions: Drug: ABT-335; Drug: rosuvastatin calcium; Drug: simvastatin; Drug: atorvastatin calcium

• Registration Number: NCT00491530
• Lead Sponsor: Abbott

Brief Summary

The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-26
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-11-03
• Results First Submitted QC: 2009-11-03
• Results First Posted: 2009-12-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Adult male and female subjects who voluntarily sign the informed consent.
• Subject has successfully completed the treatment phase of the preceding open-label year 1 study.

Exclusion Criteria

• Subject is using or will use investigational medications, except as approved by Abbott.
• Subject has prematurely discontinued his/her combination therapy administered in the preceding open-label year 1 study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-335 + rosuvastatin calcium	rosuvastatin calcium	-
ABT-335 + simvastatin	simvastatin	-
ABT-335 + atorvastatin calcium	ABT-335	-
ABT-335 + atorvastatin calcium	atorvastatin calcium	-
ABT-335 + rosuvastatin calcium	ABT-335	-
ABT-335 + simvastatin	ABT-335	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study	Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.	All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.

Secondary Outcome Measures

Name	Time	Method
Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	\[(Week 104 triglycerides minus baseline triglycerides)/baseline triglycerides\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	\[(Week 104 HDL-C minus baseline HDL-C)/baseline HDL-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	\[(Week 104 LDL-C minus baseline LDL-C)/baseline LDL-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	\[(Week 104 Non-HDL-C minus baseline Non-HDL-C)/baseline Non-HDL-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	\[(Week 104 VLDL-C minus baseline VLDL-C)/baseline VLDL-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.
Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	\[(Week 104 Total-C minus baseline Total-C)/baseline Total-C\] X 100. Baseline is the last value prior to the first dose of combination therapy.

Trial Locations

Locations (1)

Medical Information Specialist; 🇺🇸 Abbott Park, Illinois, United States