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

• ClinicalTrials.gov Identifier: NCT01613729
• Recruitment Status: Unknown
• First Posted: June 7, 2012
• Last Update Posted: September 25, 2012
• Sponsor: D16 Pharma & Biotec Ltd.
• Collaborators: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh; Dhaka Medical College; National Institute of Cardiovascular Diseases
• Information provided by (Responsible Party): D16 Pharma & Biotec Ltd.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Dyslipidemia	Drug: Rosuvastatin 5 mg; Drug: Rosuvastatin 10 mg	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2000 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: July 2012
• Estimated Primary Completion Date: July 2013
• Estimated Study Completion Date: December 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. To compare the safety [ Time Frame: 24 weeks ]

   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Bangladesh

BSMMU

Dhaka, Bangladesh, 1000

Sponsors and Collaborators

D16 Pharma & Biotec Ltd.

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

More Information

• Responsible Party: D16 Pharma & Biotec Ltd.
• ClinicalTrials.gov Identifier: NCT01613729
• Other Study ID Numbers: corestin/bd/2012-16
• First Posted: June 7, 2012
• Last Update Posted: September 25, 2012
• Last Verified: September 2012

Keywords provided by D16 Pharma & Biotec Ltd.:

Dyslipidemia; Rosuvastatin; Efficacy; Safety

Additional relevant MeSH terms:

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Rosuvastatin Calcium; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors