CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,445 enrolled
Drug / intervention
ABT-335 +2 moredrug
Likely dose
ABT-335 (fenofibric acid) 135 mg daily; rosuvastatin calcium daily (dose variable by arm)AI-extracted
Key inclusion· 1
  • ✓Diagnosis of mixed dyslipidemia
Key exclusion· 3
  • ✕Unstable medical conditions or medical conditions considered inappropriate in a clinical trial
  • ✕Taking certain medications or unstable dose of specific medications
  • ✕Pregnant, planning pregnancy, or lactating

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

Search/NCT00300482
NCT00300482Phase 3Completed
CompareCT.gov

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

Abbott·interventional·Posted Mar 9, 2006·Updated Jun 10, 2009

In Brief

A Phase 3 clinical trial evaluating ABT-335, Rosuvastatin Calcium, and 1 other intervention for Dyslipidemia and 2 related conditions. Completed, enrolled 1,445 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy in subjects with multiple 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 StartMar 1, 2006
Primary CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 20.3 years ago

Interventions

ABT-335drug

135 mg, daily, 12 weeks

Rosuvastatin Calciumdrug

Daily, 12 weeks, see Arm Description for dosage information

Placebodrug

Daily, 12 weeks, see Arm Description for information regarding placebo type