NCT03949374

Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients

A 8-week, Single Center, Randomized, Open-label, Parallel-group, Non-inferiority Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This 8 weeks, prospective, single center, randomized, open-label, parallel-group, non-inferiority study was performed from October 2015 to April 2018. This study as designed to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin, ROVASRO®) compared to the reference formulation (rosuvastatin, CRESTOR®) in patients with primary hypercholesterolemia and complex dyslipidemia.

Conditions

• Hypercholesterolemia
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	CRESTOR, reference formulation of rosuvastatin	Use of ROVASRO for hypercholesterolemia
DRUG	ROVASRO, generic formulation of rosuvastatin	Use of CRESTOR for hypercholesterolemia

Timeline

• Start date: 2015-10-23
• Primary completion: 2018-04-16
• Completion: 2018-06-01
• First posted: 2019-05-14
• Last updated: 2019-05-14

Locations

1 site across 1 country: South Korea