Hyperlipidemia Clinical Trial
NCT number | NCT02280590 |
Other study ID # | CNT_HLP_IV |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | October 29, 2014 |
Last updated | July 2, 2015 |
Start date | September 2014 |
Verified date | July 2015 |
Source | Dong-A ST Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 223 |
Est. completion date | |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Dong-A ST Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percent change in LDL-C | After taken medication for 8 weeks | No | |
Secondary | The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C | After taken medication for 8 weeks | No | |
Secondary | 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 | After taken medication for 8 weeks | No |
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