CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,220 enrolled
Drug / intervention
Comparator: ezetimibe/simvastatin + niacin (ER) +7 moredrug
Likely dose
Ezetimibe/simvastatin 10/20 mg + niacin ER 2 g orally once dailyAI-extracted
Key inclusion· 3
  • ✓LDL cholesterol 130–190 mg/dL
  • ✓Triglycerides ≤500 mg/dL
  • ✓Willing to adhere to a low-cholesterol diet
Key exclusion· 4
  • ✕Pregnant, lactating, or planning to become pregnant
  • ✕Known sensitivity or intolerance to ezetimibe, simvastatin, or the ezetimibe/simvastatin combination
  • ✕Known sensitivity or intolerance to niacin, any niacin ER component, or aspirin
  • ✕Cannot safely discontinue existing lipid-lowering therapy

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

Search/NCT00271817
NCT00271817Phase 3Completed
CompareCT.gov

Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia

Organon and Co·interventional·Posted Jan 4, 2006·Updated May 16, 2024

In Brief

A Phase 3 clinical trial evaluating Comparator: ezetimibe/simvastatin + niacin (ER), Comparator: Placebo to ezetimibe/simvastatin, and 6 other interventions for Hypercholesterolemia. Completed, enrolled 1,220 participants.

Detailed Summary

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2006
Enrollment StartDec 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.5 years ago

Interventions

Comparator: ezetimibe/simvastatin + niacin (ER)drug

ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks

Comparator: Placebo to ezetimibe/simvastatindrug

ezetimibe/simvastatin (Pbo) tablet. Treatment time will be \~24 weeks.

Comparator: niacin (ER) tabletdrug

niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks

Comparator: ezetimibe (+) simvastatindrug

ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~24 weeks.

Comparator: Placebo to Niacin (ER)drug

Niacin (ER) (Pbo) tablet. Treatment time will be \~24 weeks.

Comparator: ezetimibe/simvastatin and niacin (ER)drug

ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be \~40 additional weeks for a total of 64 weeks

Comparator: ezetimibe and simvastatindrug

ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks

Comparator: Placebo to niacin (ER)drug

Niacin (ER) (Pbo) tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks