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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02445352
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Alvogen Korea

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

Condition or disease Intervention/treatment Phase
Primary Hypercholesterolemia Drug: Rosuvastatin 5mg Drug: DP-R207 5/10mg Drug: Rosuvastatin 10mg Drug: DP-R207 10/10mg Drug: Rosuvastatin 20mg Drug: DP-R207 20/10mg Drug: Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg) Drug: Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg) Drug: Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 379 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015


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: DP-R207 5/10mg
Other Names:
  • Rosuvastatin 5mg
  • Ezetimibe 10mg

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

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

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



Primary Outcome Measures :
  1. Percent change from baseline to 8 weeks in LDL-Cholesterol [ Time Frame: baseline and 8 weeks ]

Secondary Outcome Measures :
  1. Percent change from baseline to 4 weeks in LDL-Cholesterol [ Time Frame: baseline and 4 weeks ]
  2. Percent change from baseline to 4 weeks in lipid related blood test results [ Time Frame: baseline and 4 weeks ]
  3. Percent change from baseline to 8 weeks in lipid related blood test results [ Time Frame: baseline and 8 weeks ]
  4. Percentage of patients reaching treatment goals according to NCEP ATP III Guideline [ Time Frame: week 4 and week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445352


Locations
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Korea, Republic of
Severance Hospital
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Alvogen Korea
Investigators
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Study Chair: Yangsoo Jang, Ph.D. Severance Hospital

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Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT02445352    
Other Study ID Numbers: DP-CTR207-III-02
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors