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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2012 by D16 Pharma & Biotec Ltd..
Recruitment status was: Enrolling by invitation

Sponsor:

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.

ClinicalTrials.gov Identifier:

NCT01613729

First received: June 4, 2012

Last updated: September 22, 2012

Last verified: September 2012

History of Changes

Purpose

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	Intervention	Phase
Dyslipidemia	Drug: Rosuvastatin 5 mg Drug: Rosuvastatin 10 mg	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by D16 Pharma & Biotec Ltd.:

Primary Outcome Measures:

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:

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.


Estimated Enrollment:	2000
Study Start Date:	July 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Detailed Description:

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).

Eligibility


Ages Eligible for Study:	45 Years to 75 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613729

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 History of Changes
Other Study ID Numbers:	corestin/bd/2012-16
Study First Received:	June 4, 2012
Last Updated:	September 22, 2012

Keywords provided by D16 Pharma & Biotec Ltd.:


Dyslipidemia Rosuvastatin Efficacy Safety

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 20, 2017

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