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
1 other identifier
interventional
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 25, 2012
September 1, 2012
1 year
June 4, 2012
September 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
24 weeks
Secondary Outcomes (1)
To compare the safety
24 weeks
Study Arms (2)
Rosuvastation 5 Initiator Arm
ACTIVE COMPARATORThese patients will start the study with Rosuvastatin 5 mg and then after 12 weks they will be switched to Rosuvastatin 10 mg.
Rosuvastatin 10 initiator arm
ACTIVE COMPARATORThese patients will continue with Rosuvastatin 10 mg and after 12 weeks they will be switched to Rosuvastatin 5 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- D16 Pharma & Biotec Ltd.lead
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladeshcollaborator
- Dhaka Medical Collegecollaborator
- National Institute of Cardiovascular Diseasescollaborator
Study Sites (1)
BSMMU
Dhaka, Dhaka Division, 1000, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nazrul Islam, FCPS
Professor of Cardiology
- STUDY DIRECTOR
Pinaki Bhattacharya, MBBS
D16 Pharma & Biotec
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 7, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2013
Study Completion
December 1, 2013
Last Updated
September 25, 2012
Record last verified: 2012-09