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NCT02251847 Clinical Trial

The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02251847
Other study ID # ID-ROEZ-301
Secondary ID
Status Recruiting
Phase Phase 3
First received September 25, 2014
Last updated September 25, 2014
Start date July 2014

Study information
Verified date September 2014
Source IlDong Pharmaceutical Co Ltd
Contact Min-Hee Kwon
Phone 02-526-3379
Email minhee@ildong.com
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Description:

To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria:

- Hypercholesterolemic patient

Exclusion Criteria:

- Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rosuvastatin/Ezetimibe
Rosuvastatin 5mg

Locations
Country Name City State
Korea, Republic of Gil Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from baseline to 8 week in LDL-Cholesterol baseline and 8 week No
Secondary Percent change from baseline to 4 week in LDL-Cholesterol baseline and 4 week No
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