drugset / Trial / NCT01613729
Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin
Phase 4
Unknown
2000 enrolled
D16 Pharma & Biotec Ltd.
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · collabDhaka Medical College · collabNational Institute of Cardiovascular Diseases · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2012-07
- Primary completion
- 2013-07
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rosuvastatin | Small molecule | 5 mg | — |
| Comparator | Rosuvastatin | Small molecule | 10 mg | — |