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Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia

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: NCT02280590
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Brief Summary:

Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia

- 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design


Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Rosuvastatin(Cresnon®) Drug: Rosuvastatin(Crestor®) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2014
Actual Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cresnon®
Rosuvastatin 10mg, tablet, q.d.
Drug: Rosuvastatin(Cresnon®)
10mg

Active Comparator: Crestor®
Rosuvastatin 10mg, tablet, q.d.
Drug: Rosuvastatin(Crestor®)
10mg




Primary Outcome Measures :
  1. The percent change in LDL-C [ Time Frame: After taken medication for 8 weeks ]

Secondary Outcome Measures :
  1. The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C [ Time Frame: After taken medication for 8 weeks ]
  2. The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis [ Time Frame: After taken medication for 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 20
  • Persons who have not reached LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis

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): NCT02280590


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02280590    
Other Study ID Numbers: CNT_HLP_IV
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors