Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia
NCT ID: NCT01914432
Last Updated: 2014-07-08
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
210 participants
INTERVENTIONAL
2013-11-30
2014-06-30
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
QUADRUPLE
Study Groups
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YH16410
PO, Once Daily, 8 weeks
YH16410
Rosuvastatin placebo
Telmisartan placebo
Rosuvastatin
PO, Once Daily, 8 weeks
Rosuvastatin
YH16410 placebo
Telmisartan placebo
Telmisartan
PO, Once Daily, 8 weeks
Telmisartan
YH16410 placebo
Rosuvastatin placebo
Placebo
PO, Once Daily, 8 weeks
YH16410 placebo
Rosuvastatin placebo
Telmisartan placebo
Interventions
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YH16410
Rosuvastatin
Telmisartan
YH16410 placebo
Rosuvastatin placebo
Telmisartan placebo
Eligibility Criteria
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Inclusion Criteria
* Men and women ≥ 19 years of age
* Subject who has one of 3 conditions classified by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, TG, Coronary Artery Disease and Equivalent
Exclusion Criteria
* Other exclusions applied
19 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Su Youn Nam, MD
Role: STUDY_DIRECTOR
Yuhan Corporation
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Oh GC, Han JK, Han KH, Hyon MS, Doh JH, Kim MH, Jeong JO, Bae JH, Kim SH, Yoo BS, Baek SH, Rhee MY, Ihm SH, Sung JH, Choi YJ, Kim SJ, Hong KS, Lee BK, Cho J, Shin ES, Rhew JY, Kim H, Kim HS. Efficacy and Safety of Fixed-dose Combination Therapy With Telmisartan and Rosuvastatin in Korean Patients With Hypertension and Dyslipidemia: TELSTA-YU (TELmisartan-rosuvaSTAtin from YUhan), a Multicenter, Randomized, 4-arm, Double-blind, Placebo-controlled, Phase III Study. Clin Ther. 2018 May;40(5):676-691.e1. doi: 10.1016/j.clinthera.2018.03.010. Epub 2018 Apr 17.
Other Identifiers
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YH16410-301
Identifier Type: -
Identifier Source: org_study_id
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