CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Atorvastatin/niacin extended-release +3 moredrug
Likely dose
Atorvastatin/niacin extended-release 80 mgfrom 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/NCT00804843
NCT00804843Phase 2Completed
CompareCT.gov

A Randomized Clinical Trial to Evaluate the Effects of High Dose Statin and Niacin Therapy on Excised Plaque Biomarkers in Patients Undergoing Carotid Endarterectomy (CEA)

Merck Sharp & Dohme LLC·interventional·Posted Dec 9, 2008·Updated Sep 30, 2015

In Brief

A Phase 2 clinical trial evaluating Atorvastatin/niacin extended-release, Atorvastatin, and 1 other intervention for Carotid Atherosclerosis. Completed, enrolled 100 participants.

Detailed Summary

This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Atherosclerosis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2008
Enrollment StartApr 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.6 years ago

Interventions

Atorvastatin/niacin extended-releasedrug

80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.

Atorvastatindrug

10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.

Simvastatindrug

(Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.

Simvastatindrug

(Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.