Clinical trial NCT00491530: A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
Official title: A Year 2, Long-Term, Open-Label, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mixed Dyslipidemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-06-26
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 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.
Secondary outcomes:
measure: Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study
timeFrame: 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)
measure: Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
timeFrame: 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)
measure: Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
timeFrame: 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)
measure: Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
timeFrame: 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)
measure: Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study
timeFrame: 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)
measure: Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study
timeFrame: 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)
Other outcomes:
Locations:
city: Abbott Park
country: United States
facility: Medical Information Specialist
state: Illinois
Study officials:
References:
citation: Kipnes MS, Roth EM, Rhyne JM, Setze CM, Lele A, Kelly MT, Sleep DJ, Stolzenbach JC. Year two assessment of fenofibric acid and moderate-dose statin combination: a phase 3, open-label, extension study. Clin Drug Investig. 2010;30(1):51-61. doi: 10.2165/11319800-000000000-00000.