A Clinical Trial to Compare the Efficacy and Safety of a Combination Therapy of Ezetimibe and Rosuvastatin Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients (I-ROSETTE Study)
NCT02749994 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 396
Last updated 2018-06-13
Summary
A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.
Conditions
Interventions
- DRUG
-
Rosuvastatin
- DRUG
-
Ezetimibe
Sponsors & Collaborators
-
IlDong Pharmaceutical Co Ltd
lead INDUSTRY
Principal Investigators
-
Hyo-soo Kim, MD/PhD · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 19 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-30
- Primary Completion
- 2017-02-28
- Completion
- 2017-02-28
Countries
- South Korea
Study Locations
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