At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 934 enrolled
Drug / intervention
Rosuvastatin +1 moredrug
Likely dose
Atorvastatin 10mgfrom 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 Randomised, Double-blind Trial to Compare the Efficacy of Rosuvastatin 5 and 10 mg to Atorvastatin 10 mg in the Treatment of High Risk Patients With Hypercholesterolemia Followed by an Open Label Treatment Period With Rosuvastatin Up-titrated to the Maximum Dose of 20 mg for Those Patients Who do Not Achieve Goal
In Brief
A Phase 3 clinical trial evaluating Rosuvastatin and Atorvastatin for Hypercholesterolemia. Completed, enrolled 934 participants across 6 sites.
Detailed Summary
This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedMay 2008
Primary CompletionJul 2009
TodayJul 2026
First PostedMay 23, 2008
Enrollment StartMay 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.1 years ago
Interventions
Rosuvastatindrug
Capsule/Tablet, oral, qd, 6 or 12 weeks
Atorvastatindrug
Capsule/Tablet, 10mg, oral, qd, 6 weeks