CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 613 enrolled
Drug / intervention
ABT-335 +2 moredrug
Likely dose
ABT-335 (fenofibric acid) 135 mg daily with or without atorvastatin daily for 12 weeksAI-extracted
Key inclusion· 1
  • ✓Diagnosis of mixed dyslipidemia
Key exclusion· 3
  • ✕Unstable medical conditions or conditions considered inappropriate for clinical trial participation
  • ✕Taking certain medications or unstable doses of specific medications
  • ✕Pregnancy, planning to become pregnant, or lactating

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00300469
NCT00300469Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects With Mixed Dyslipidemia

Abbott·interventional·Posted Mar 9, 2006·Updated Jun 3, 2009

In Brief

A Phase 3 clinical trial evaluating ABT-335, Atorvastatin, and 1 other intervention for Mixed Dyslipidemia and 2 related conditions. Completed, enrolled 613 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2006
Enrollment StartMar 1, 2006
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 20.3 years ago

Interventions

ABT-335drug

135 mg, daily, 12 weeks

Atorvastatindrug

Daily, 12 weeks, see Arm Description for dosage information

Placebodrug

daily, 12 weeks, see Arm Description for placebo information