At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,216 enrolled
Drug / intervention
Comparator: simvastatin +2 moredrug
Likely dose
Comparator: simvastatin 20mgfrom 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.
A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.
In Brief
A Phase 3 clinical trial evaluating Comparator: simvastatin, niacin (+) laropiprant, and 1 other intervention for Primary Hypercholesterolemia and Mixed Dyslipidemia. Completed, enrolled 1,216 participants.
Detailed Summary
This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hypercholesterolemia, Mixed Dyslipidemia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJul 2007
Primary CompletionJul 2008
Study CompletionOct 2008
TodayJul 2026
First PostedMay 28, 2007
Enrollment StartJul 1, 2007
Primary CompletionJul 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.1 years ago
Interventions
Comparator: simvastatindrug
simvastatin (20mg to 40mg) for 12 weeks.
niacin (+) laropiprantdrug
One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
Comparator: atorvastatin calciumdrug
atorvastatin calcium (20mg to 40mg) for 12 weeks.