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

This study is enrolling participants by invitation only.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: Cholesterol
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the safety [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

    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:

  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).
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Bangladesh: Bangladesh Medical Research Council

Keywords provided by D16 Pharma & Biotec Ltd.:
Dyslipidemia
Rosuvastatin
Efficacy
Safety

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013