CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,911 enrolled
Drug / intervention
ABT-335 and rosuvastatin calcium +2 moredrug
Likely dose
ABT-335 and rosuvastatin calcium 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.

Search/NCT00300430
NCT00300430Phase 3Completed
CompareCT.gov

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

Abbott·interventional·Posted Mar 9, 2006·Updated Jul 23, 2009

In Brief

A Phase 3 clinical trial evaluating ABT-335 and rosuvastatin calcium, ABT-335 and atorvastatin calcium, and 1 other intervention for Dyslipidemia and 2 related conditions. Completed, enrolled 1,911 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2006
Enrollment StartSep 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.3 years ago

Interventions

ABT-335 and rosuvastatin calciumdrug

ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks

ABT-335 and atorvastatin calciumdrug

ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks

ABT-335 and simvastatindrug

ABT-335 135 mg plus simvastatin daily, 52 weeks