Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin

Study Overview
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Brief Summary
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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
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This study will observe the followings: 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. To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in LDL-C (compare change from baseline). To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in LDL-C (compare values week 0 vs. week 12). To investigate the safety of Rosuvastatin in regards to liver enzyme change, kidney function and muscle toxicity. 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). 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). 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 as follows: To investigate the change in LDL-C by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24). To investigate the change in LDL-C by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24). 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). 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).

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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: Rosuvastatin 5 mg
* Drug: Rosuvastatin 10 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastation 5 Initiator Arm<br>These patients will start the study with Rosuvastatin 5 mg and then after 12 weks they will be switched to Rosuvastatin 10 mg. | Drug: Rosuvastatin 5 mg<br>* Rosuvastatin 5 mg<br>|
| Active Comparator: Rosuvastatin 10 initiator arm<br>These patients will continue with Rosuvastatin 10 mg and after 12 weeks they will be switched to Rosuvastatin 5 mg | Drug: Rosuvastatin 10 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Rosuvastatin, Efficacy, Safety