Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin

D16 Pharma & Biotec Ltd.2,000 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,000

Conditions

Dyslipidemia

Interventions

Rosuvastatin 5 mgDRUG

Rosuvastatin 5 mg

Rosuvastatin 10 mgDRUG

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

BSMMU

Dhaka, Dhaka Division, Bangladesh

Outcomes

Primary Outcomes

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.

Time frame: 24 weeks

Secondary Outcomes

To compare the safety

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.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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