Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia
NCT ID: NCT02445352
Last Updated: 2015-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
379 participants
INTERVENTIONAL
2014-07-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rosuvastatin 5mg & Placebo & Placebo
Once a day, administration of rosuvastatin 5mg and two types of placebo for 20 weeks
Rosuvastatin 5mg
Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
DP-R207 5/10mg & Placebo & Placebo
Once a day, administration of DP-R207 5/10mg and two types of placebo for 20 weeks
DP-R207 5/10mg
Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Rosuvastatin 10mg & Placebo & Placebo
Once a day, administration of rosuvastatin 10mg and two types of placebo for 20 weeks
Rosuvastatin 10mg
Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
DP-R207 10/10mg & Placebo & Placebo
Once a day, administration of DP-R207 10/10mg and two types of placebo for 20 weeks
DP-R207 10/10mg
Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Rosuvastatin 20mg & Placebo & Placebo
Once a day, administration of rosuvastatin 20mg and two types of placebo for 20 weeks
Rosuvastatin 20mg
Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
DP-R207 20/10mg & Placebo & Placebo
Once a day, administration of DP-R207 20/10mg and two types of placebo for 20 weeks
DP-R207 20/10mg
Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
Interventions
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Rosuvastatin 5mg
DP-R207 5/10mg
Rosuvastatin 10mg
DP-R207 10/10mg
Rosuvastatin 20mg
DP-R207 20/10mg
Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)
Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)
Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent form
* At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL
Exclusion Criteria
* Liver transaminases \> 2 x upper limit of normal
19 Years
ALL
No
Sponsors
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Alvogen Korea
INDUSTRY
Responsible Party
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Principal Investigators
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Yangsoo Jang, Ph.D.
Role: STUDY_CHAIR
Severance Hospital
Locations
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Severance Hospital
Seodaemun-gu, Seoul, South Korea
Countries
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Other Identifiers
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DP-CTR207-III-02
Identifier Type: -
Identifier Source: org_study_id
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