Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia
ROSE
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
1 other identifier
interventional
379
1 country
1
Brief Summary
The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 15, 2015
CompletedMay 15, 2015
May 1, 2015
6 months
May 13, 2015
May 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change from baseline to 8 weeks in LDL-Cholesterol
baseline and 8 weeks
Secondary Outcomes (4)
Percent change from baseline to 4 weeks in LDL-Cholesterol
baseline and 4 weeks
Percent change from baseline to 4 weeks in lipid related blood test results
baseline and 4 weeks
Percent change from baseline to 8 weeks in lipid related blood test results
baseline and 8 weeks
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
week 4 and week 8
Study Arms (6)
Rosuvastatin 5mg & Placebo & Placebo
ACTIVE COMPARATOROnce a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks
DP-R207 5/10mg & Placebo & Placebo
EXPERIMENTALOnce a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks
Rosuvastatin 10mg & Placebo & Placebo
ACTIVE COMPARATOROnce a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
DP-R207 10/10mg & Placebo & Placebo
EXPERIMENTALOnce a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks
Rosuvastatin 20mg & Placebo & Placebo
ACTIVE COMPARATOROnce a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks
DP-R207 20/10mg & Placebo & Placebo
EXPERIMENTALOnce a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Aged over 19 years
- Signed informed consent form
- At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL
You may not qualify if:
- Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe
- Liver transaminases \> 2 x upper limit of normal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alvogen Korealead
Study Sites (1)
Severance Hospital
Seodaemun-gu, Seoul, 120-752, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yangsoo Jang, Ph.D.
Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 15, 2015
Study Start
July 1, 2014
Primary Completion
January 1, 2015
Study Completion
March 1, 2015
Last Updated
May 15, 2015
Record last verified: 2015-05