Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin
NCT ID: NCT01613729
Last Updated: 2012-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
2000 participants
INTERVENTIONAL
2012-07-31
2013-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
Rosuvastatin 5 mg
Rosuvastatin 5 mg
Rosuvastatin 10 initiator arm
These patients will continue with Rosuvastatin 10 mg and after 12 weeks they will be switched to Rosuvastatin 5 mg
Rosuvastatin 10 mg
Interventions
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Rosuvastatin 5 mg
Rosuvastatin 5 mg
Rosuvastatin 10 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* Active liver disease/severe hepatic impairment
* Treatment with cyclosporin or any disallowed drug
* Patients with unstable angina pectoris
45 Years
75 Years
ALL
No
Sponsors
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
OTHER
Dhaka Medical College
OTHER
National Institute of Cardiovascular Diseases
UNKNOWN
D16 Pharma & Biotec Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Nazrul Islam, FCPS
Role: PRINCIPAL_INVESTIGATOR
Professor of Cardiology
Pinaki Bhattacharya, MBBS
Role: STUDY_DIRECTOR
D16 Pharma & Biotec
Locations
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BSMMU
Dhaka, Dhaka Division, Bangladesh
Countries
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Other Identifiers
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corestin/bd/2012-16
Identifier Type: -
Identifier Source: org_study_id