Back to resultsEfficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia (ROSE)
Primary Purpose
Primary Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
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)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia
Eligibility Criteria
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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
Rosuvastatin 5mg & Placebo & Placebo
DP-R207 5/10mg & Placebo & Placebo
Rosuvastatin 10mg & Placebo & Placebo
DP-R207 10/10mg & Placebo & Placebo
Rosuvastatin 20mg & Placebo & Placebo
DP-R207 20/10mg & Placebo & Placebo
Arm Description
Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks
Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks
Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks
Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks
Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks
Outcomes
Primary Outcome Measures
Percent change from baseline to 8 weeks in LDL-Cholesterol
Secondary Outcome Measures
Percent change from baseline to 4 weeks in LDL-Cholesterol
Percent change from baseline to 4 weeks in lipid related blood test results
Percent change from baseline to 8 weeks in lipid related blood test results
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02445352
Brief Title
Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alvogen Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
379 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin 5mg & Placebo & Placebo
Arm Type
Active Comparator
Arm Description
Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks
Arm Title
DP-R207 5/10mg & Placebo & Placebo
Arm Type
Experimental
Arm Description
Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks
Arm Title
Rosuvastatin 10mg & Placebo & Placebo
Arm Type
Active Comparator
Arm Description
Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
Arm Title
DP-R207 10/10mg & Placebo & Placebo
Arm Type
Experimental
Arm Description
Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks
Arm Title
Rosuvastatin 20mg & Placebo & Placebo
Arm Type
Active Comparator
Arm Description
Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks
Arm Title
DP-R207 20/10mg & Placebo & Placebo
Arm Type
Experimental
Arm Description
Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 5mg
Intervention Type
Drug
Intervention Name(s)
DP-R207 5/10mg
Other Intervention Name(s)
Rosuvastatin 5mg, Ezetimibe 10mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 10mg
Intervention Type
Drug
Intervention Name(s)
DP-R207 10/10mg
Other Intervention Name(s)
Rosuvastatin 10mg, Ezetimibe 10mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20mg
Intervention Type
Drug
Intervention Name(s)
DP-R207 20/10mg
Other Intervention Name(s)
Rosuvastatin 20mg, Ezetimibe 10mg
Intervention Type
Drug
Intervention Name(s)
Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Intervention Type
Drug
Intervention Name(s)
Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
Intervention Type
Drug
Intervention Name(s)
Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Primary Outcome Measure Information:
Title
Percent change from baseline to 8 weeks in LDL-Cholesterol
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline to 4 weeks in LDL-Cholesterol
Time Frame
baseline and 4 weeks
Title
Percent change from baseline to 4 weeks in lipid related blood test results
Time Frame
baseline and 4 weeks
Title
Percent change from baseline to 8 weeks in lipid related blood test results
Time Frame
baseline and 8 weeks
Title
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
Time Frame
week 4 and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yangsoo Jang, Ph.D.
Organizational Affiliation
Severance Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Severance Hospital
City
Seodaemun-gu
State/Province
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia
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