Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin (Cor16)

D16 Pharma & Biotec

Status and phase: Unknown; Phase 4

Conditions: Dyslipidemia

Treatments: Drug: Rosuvastatin 10 mg; Drug: Rosuvastatin 5 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01613729

corestin/bd/2012-16

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,000 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Rosuvastation 5 Initiator Arm

Active Comparator group

Description:

These patients will start the study with Rosuvastatin 5 mg and then after 12 weks they will be switched to Rosuvastatin 10 mg.

Treatment:

Drug: Rosuvastatin 5 mg

Rosuvastatin 10 initiator arm

Active Comparator group

Description:

These patients will continue with Rosuvastatin 10 mg and after 12 weeks they will be switched to Rosuvastatin 5 mg

Treatment:

Drug: Rosuvastatin 10 mg