Back to resultsComparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin(Cresnon®)
Rosuvastatin(Crestor®)
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 20
- Persons who have not reached LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cresnon®
Crestor®
Arm Description
Rosuvastatin 10mg, tablet, q.d.
Rosuvastatin 10mg, tablet, q.d.
Outcomes
Primary Outcome Measures
The percent change in LDL-C
Secondary Outcome Measures
The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C
The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02280590
Brief Title
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia
- 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cresnon®
Arm Type
Experimental
Arm Description
Rosuvastatin 10mg, tablet, q.d.
Arm Title
Crestor®
Arm Type
Active Comparator
Arm Description
Rosuvastatin 10mg, tablet, q.d.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin(Cresnon®)
Intervention Description
10mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin(Crestor®)
Intervention Description
10mg
Primary Outcome Measure Information:
Title
The percent change in LDL-C
Time Frame
After taken medication for 8 weeks
Secondary Outcome Measure Information:
Title
The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C
Time Frame
After taken medication for 8 weeks
Title
The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
Time Frame
After taken medication for 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 20
Persons who have not reached LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
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