CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 657 enrolled
Drug / intervention
ABT-335 +2 moredrug
Likely dose
ABT-335 135 mg orally once daily; Simvastatin dosage per arm description (not specified in abstract); 12 weeks durationAI-extracted
Key inclusion· 3
  • ✓Diagnosis of mixed dyslipidemia
  • ✓Agreement to use adequate birth control methods
  • ✓Agreement to adhere to the American Heart Association (AHA) diet
Key exclusion· 3
  • ✕Unstable medical conditions or medical conditions considered inappropriate for clinical trial participation
  • ✕Use of certain medications or unstable dosing of specific medications
  • ✕Pregnancy, planning pregnancy, or lactation

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

Search/NCT00300456
NCT00300456Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin 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, Simvastatin, and 1 other intervention for Dyslipidemia and 2 related conditions. Completed, enrolled 657 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin 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 CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.3 years ago

Interventions

ABT-335drug

135 mg, daily, 12 weeks

Simvastatindrug

daily, 12 weeks, see Arm Description for dosage information

Placebodrug

Daily, 12 weeks, see Arm Description for placebo information