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

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemia

Treatments: Drug: Rosuvastatin(Cresnon®); Drug: Rosuvastatin(Crestor®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02280590

CNT_HLP_IV

Details and patient eligibility

About

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

Enrollment: 223 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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223 participants in 2 patient groups

Cresnon®

Experimental group

Description:

Rosuvastatin 10mg, tablet, q.d.

Treatment:

Drug: Rosuvastatin(Cresnon®)

Crestor®

Active Comparator group

Description:

Rosuvastatin 10mg, tablet, q.d.

Treatment:

Drug: Rosuvastatin(Crestor®)