CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 682 enrolled
Drug / intervention
ABT-335 +2 moredrug
Likely dose
Not stated in 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/NCT00616772
NCT00616772Phase 3Completed
CompareCT.gov

Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects With Type IIb Dyslipidemia With Residual Risk in Addition to Atorvastatin Therapy (FIRST) Trial

AbbVie (prior sponsor, Abbott)·interventional·Posted Feb 15, 2008·Updated Jul 2, 2018

In Brief

A Phase 3 clinical trial evaluating ABT-335, Placebo, and 1 other intervention for Coronary Artery Disease and 2 related conditions. Completed, enrolled 682 participants across 124 sites.

Detailed Summary

The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Coronary Heart Disease, Dyslipidemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 15, 2008
Enrollment StartFeb 1, 2008
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 18.4 years ago

Interventions

ABT-335drug

Capsule

Placebodrug

Capsule

Atorvastatinother

Capsule