At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 543 enrolled
Drug / intervention
ABT-335 +3 moredrug
Likely dose
ABT-335 135 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia
In Brief
A Phase 3 clinical trial evaluating ABT-335, placebo, and 2 other interventions for Dyslipidemias and 3 related conditions. Completed, enrolled 543 participants across 118 sites.
Detailed Summary
The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia, Mixed Dyslipidemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedMar 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedMar 20, 2008
Enrollment StartFeb 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.3 years ago
Interventions
ABT-335drug
135 mg capsule, daily, 12 weeks
placebodrug
placebo capsule, daily, 12 weeks
atorvastatindrug
40 mg, tablet, daily, 12 weeks
ezetimibedrug
10 mg capsule, daily, 12 weeks