Dyslipidemia
Conditions
Keywords
Dyslipidemia, Rosuvastatin, Efficacy, Safety
Brief 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).
Interventions
Rosuvastatin 5 mg
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Dhaka Medical College
National Institute of Cardiovascular Diseases
D16 Pharma & Biotec Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the safety | 24 weeks | To investigate the effect of 12 weeks therapy on change in microalbuminuria in each treatment group (compare change from baseline). 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 to investigate the safety of Rosuvastatin in regards to Liver enzyme change, kidney function and muscle toxicity. |
Countries
Bangladesh
Outcome results
None listed