- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02280590
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
July 2, 2015 updated by: Dong-A ST Co., Ltd.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
223
Phase
- Phase 4
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
-
-
-
Seoul, Korea, Republic of
- Seoul National University 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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cresnon®
Rosuvastatin 10mg, tablet, q.d.
|
10mg
|
Active Comparator: Crestor®
Rosuvastatin 10mg, tablet, q.d.
|
10mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percent change in LDL-C
Time Frame: After taken medication for 8 weeks
|
After taken medication for 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After taken medication for 8 weeks
|
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
|
After taken medication for 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
October 29, 2014
First Submitted That Met QC Criteria
October 29, 2014
First Posted (Estimate)
October 31, 2014
Study Record Updates
Last Update Posted (Estimate)
July 7, 2015
Last Update Submitted That Met QC Criteria
July 2, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Hyperlipoproteinemias
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- CNT_HLP_IV
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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