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

May 14, 2015 updated by: Alvogen Korea

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

379

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Seodaemun-gu, Seoul, Korea, Republic of, 120-752
        • Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rosuvastatin 5mg & Placebo & Placebo
Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks
Drug: Rosuvastatin 5mg
Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Experimental: DP-R207 5/10mg & Placebo & Placebo
Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks
Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Drug: DP-R207 5/10mg
Other Names:
  • Rosuvastatin 5mg
  • Ezetimibe 10mg
Active Comparator: Rosuvastatin 10mg & Placebo & Placebo
Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Drug: Rosuvastatin 10mg
Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Experimental: DP-R207 10/10mg & Placebo & Placebo
Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks
Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Drug: DP-R207 10/10mg
Other Names:
  • Ezetimibe 10mg
  • Rosuvastatin 10mg
Active Comparator: Rosuvastatin 20mg & Placebo & Placebo
Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks
Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Drug: Rosuvastatin 20mg
Experimental: DP-R207 20/10mg & Placebo & Placebo
Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks
Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Drug: DP-R207 20/10mg
Other Names:
  • Ezetimibe 10mg
  • Rosuvastatin 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to 8 weeks in LDL-Cholesterol
Time Frame: baseline and 8 weeks
baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to 4 weeks in LDL-Cholesterol
Time Frame: baseline and 4 weeks
baseline and 4 weeks
Percent change from baseline to 4 weeks in lipid related blood test results
Time Frame: baseline and 4 weeks
baseline and 4 weeks
Percent change from baseline to 8 weeks in lipid related blood test results
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
Time Frame: week 4 and week 8
week 4 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvogen Korea

Investigators

  • Study Chair: Yangsoo Jang, Ph.D., Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

May 15, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-CTR207-III-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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