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NCT02280590 Clinical Trial

Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia

Hyperlipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
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

Clinical Trial 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

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rosuvastatin(Cresnon®)
10mg
• Rosuvastatin(Crestor®)
10mg

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
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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