Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin

Dyslipidemia Clinical Trial

— Cor16  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01613729
• Other study ID #: corestin/bd/2012-16
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: June 4, 2012
• Last updated: September 22, 2012
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2012
• Source: D16 Pharma & Biotec Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Bangladesh Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Rosuvastatin 5 mg
Rosuvastatin 5 mg
• Rosuvastatin 10 mg

Locations

Country	Name	City	State
Bangladesh	BSMMU	Dhaka

Sponsors (4)

Lead Sponsor	Collaborator
D16 Pharma & Biotec Ltd.	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Dhaka Medical College, National Institute of Cardiovascular Diseases

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes