Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia

Primary Hypercholesterolemia Clinical Trial

— ROSE  

Official title:

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R207 (Rosuvastatin /Ezetimibe Combination) and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445352
• Other study ID #: DP-CTR207-III-02
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2015
• Last updated: May 14, 2015
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Alvogen Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Aged over 19 years

• Signed informed consent form

• At visit 1 and visit 2, LDL-Cholesterol = 250mg/dL and Triglyderide = 350mg/dL

Exclusion Criteria:

• Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe

• Liver transaminases > 2 x upper limit of normal

Study Design

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin 5mg

• DP-R207 5/10mg

• Rosuvastatin 10mg

• DP-R207 10/10mg

• Rosuvastatin 20mg

• DP-R207 20/10mg

• Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)

• Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)

• Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seodaemun-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Alvogen Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline to 8 weeks in LDL-Cholesterol		baseline and 8 weeks	No
Secondary	Percent change from baseline to 4 weeks in LDL-Cholesterol		baseline and 4 weeks	No
Secondary	Percent change from baseline to 4 weeks in lipid related blood test results		baseline and 4 weeks	No
Secondary	Percent change from baseline to 8 weeks in lipid related blood test results		baseline and 8 weeks	No
Secondary	Percentage of patients reaching treatment goals according to NCEP ATP III Guideline		week 4 and week 8	No