NCT01613729

Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin

An Open-label, Randomized, Multi-centre, Phase IVb, Parallel Study Group to Compare the Efficacy and Safety of 5 mg and 10 mg Rosuvastatin

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: D16 Pharma & Biotec Ltd. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will observe the followings: 1. To compare the effect of 5 mg/10 mg Rosuvastatin by assessment of the number of patients reaching LDL-C target goal after 24 weeks of therapy. 2. To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in LDL-C (compare change from baseline). 3. To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in LDL-C (compare values week 0 vs. week 12). 4. To investigate the safety of Rosuvastatin in regards to liver enzyme change, kidney function and muscle toxicity. 5. To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare change from baseline). 6. To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare values week 0 vs. week 12). 7. To investigate the effect of 12 weeks therapy on change in microalbuminuria in each treatment group (compare change from baseline). 8. To investigate the effect of 12 weeks therapy on change in BMI (compare change from baseline). The effects of the dose increase and the dose decrease from weeks 12 to 24 will be evaluated as follows: 9. To investigate the change in LDL-C by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24). 10. To investigate the change in LDL-C by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24). 11. To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24). 12. To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24).

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Rosuvastatin 5 mg	Rosuvastatin 5 mg
DRUG	Rosuvastatin 10 mg

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-07-01
• Completion: 2013-12-01
• First posted: 2012-06-07
• Last updated: 2012-09-25

Locations

1 site across 1 country: Bangladesh