drugset / Trial / NCT00683618

Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia

NCT00683618 ↗

Phase 3 Completed 934 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-05
Primary completion
2009-07
Completion
2009-07

Outcome

Met primary endpoint

paper CONCLUSION: Rosuvastatin 5 mg demonstrated non-inferiority and rosuvastatin 10 mg demonstrated superiority to atorvastatin 10 mg for lowering LDL-C PMID 28836458 ↗

paper Compared with atorvastatin 10 mg, rosuvastatin 5 mg (-41.70% vs. -38.67%, p = .132) and rosuvastatin 10 mg showed greater LDL-C reduction (-46.28% vs. -38.67%, p = .0002). PMID 28836458 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 10 mg Oral
Subject Rosuvastatin Small molecule 5 mg Oral
Subject Rosuvastatin Small molecule 10 mg Oral
Subject Rosuvastatin Small molecule 20 mg Oral

Indications