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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2016 |
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Main ID: |
NCT02979704 |
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Date of registration:
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31/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia
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Scientific title:
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Randomized. Open Label Trial of Comparison Between Rosuvastatin and Atorvastatin on Oxidative Stress, Inflammatory and Thrombogenic Biomarkers in Patients With Hyperlipidemia |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02979704 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Samia Tonu, MBBS |
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Address:
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Telephone:
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+8801769350011 |
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Email:
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tonusamia@gmail.com |
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Affiliation:
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Name:
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Samia Tonu, MBBS |
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Address:
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Telephone:
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+8801769350011 |
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Email:
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tonusamia@gmail.com |
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Affiliation:
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Name:
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Samia Tonu, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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BSMMU |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Age from (20-75) yrs, both male and female having LDL cholesterol: 160-190 mg/dl,
triglyceride (TG): 200-499 mg/dl will be recruited in the study
Exclusion criteria:
- Patients age <25 years or >75 years
- Patients are on lipid lowering medications
- Patients taking omega-3 fatty acid or garlic
- Patients with history of hypersensitivity on any member of statin
- Patients taking anti-inflammatory medications (steroid or NSAIDS)
- Patients taking antioxidant vitamins (vitamin A, C, E)
- Patients with impaired renal function
- Patients with impaired liver function
- Pregnant women and nursing mother
- Patients having serious infections or terminal illness
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperlipidemia
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Intervention(s)
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Drug: Atorvastatin
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Drug: Rosuvastatin
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Primary Outcome(s)
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Establishment of superiority between rosuvastatin and atorvastatin on reduction platelet count in patients with hyperlipidemia
[Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]]
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Establishment of superiority between rosuvastatin and atorvastatin on increase prothrombin time in patients with hyperlipidemia
[Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]]
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Establishment of superiority between rosuvastatin and atorvastatin on reduction of MDA in patients with hyperlipidemia
[Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]]
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Establishment of superiority between rosuvastatin and atorvastatin on reduction of inflammation in patients with hyperlipidemia
[Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]]
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Establishment of superiority between rosuvastatin and atorvastatin on increase level of erythrocytic GSH in patients with hyperlipidemia
[Time Frame: [0 weeks (baseline), 8 weeks (end)] [safety Issue: No]]
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Secondary ID(s)
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No.BSMMU/2016/8307
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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