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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Rosuvastatin 5 mg; Drug: Rosuvastatin 10 mg

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).

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • BSMMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rosuvastation 5 Initiator Arm; 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; Rosuvastatin 5 mg
Active Comparator: Rosuvastatin 10 initiator arm; These patients will continue with Rosuvastatin 10 mg and after 12 weeks they will be switched to Rosuvastatin 5 mg	Drug: Rosuvastatin 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: D16 Pharma & Biotec Ltd.
• Collaborators: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh; Dhaka Medical College; National Institute of Cardiovascular Diseases
• Investigators: Principal Investigator: Nazrul Islam, FCPS, Professor of Cardiology; Study Director: Pinaki Bhattacharya, MBBS, D16 Pharma & Biotec

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 6, 2012
• First Posted (Estimate): June 7, 2012

Study Record Updates

• Last Update Posted (Estimate): September 25, 2012
• Last Update Submitted That Met QC Criteria: September 22, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Safety; Dyslipidemia; Efficacy; Rosuvastatin
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: corestin/bd/2012-16