Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to compare the efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: D16 Pharma & Biotec Ltd.
• Collaborators: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh; Dhaka Medical College; National Institute of Cardiovascular Diseases
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Age 45 - 75 years

• LDL - C between 130 mg/dL and 250 mg/dL

• TG < 400 mg/dL

• HbA1c < 7%

• Written informed consent to participate in the trial

Exclusion Criteria:

• Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy

• Active liver disease/severe hepatic impairment

• Treatment with cyclosporin or any disallowed drug

• Patients with unstable angina pectoris