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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

June 4, 2012
September 22, 2012
July 2012
July 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01613729 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin
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.

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).
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Dyslipidemia
  • Drug: Rosuvastatin 5 mg
    Rosuvastatin 5 mg
  • Drug: Rosuvastatin 10 mg
  • 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.
    Intervention: Drug: 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
    Intervention: Drug: Rosuvastatin 10 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
2000
December 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT01613729
corestin/bd/2012-16
Yes
D16 Pharma & Biotec Ltd.
D16 Pharma & Biotec Ltd.
  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Dhaka Medical College
  • National Institute of Cardiovascular Diseases
Principal Investigator: Nazrul Islam, FCPS Professor of Cardiology
Study Director: Pinaki Bhattacharya, MBBS D16 Pharma & Biotec
D16 Pharma & Biotec Ltd.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP