Efficacy & Safety Study of YH22162 vs Telmisartan/Amlodipine in Patients With Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment
NCT ID: NCT02620163
Last Updated: 2024-11-12
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
381 participants
INTERVENTIONAL
2015-12-31
2016-12-31
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
DOUBLE
Study Groups
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YH22162
YH22162 40/5/12.5 mg (telmisartan 40/amlodipine 5mg/chlorthalidone 12.5mg) for the first 2 weeks, then force titrated to YH22162(telmisartan 80mg/amlodipine 5mg/chlorthalidone 25mg) for the remaining 6weeks
YH22162 40/5/12.5 mg
YH22162 80/5/25 mg
telmisartan/amlodipine 40/5mg placebo
telmisartan/amlodipine 80/5mg placebo
telmisartan/amlodipine
Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks
telmisartan/amlodipine 40/5mg
telmisartan/amlodipine 80/5mg
YH22162 40/5/12.5 mg placebo
YH22162 80/5/25 mg placebo
Interventions
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telmisartan/amlodipine 40/5mg
YH22162 40/5/12.5 mg
telmisartan/amlodipine 80/5mg
YH22162 80/5/25 mg
telmisartan/amlodipine 40/5mg placebo
YH22162 40/5/12.5 mg placebo
telmisartan/amlodipine 80/5mg placebo
YH22162 80/5/25 mg placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and women ≥ 19 years of age
* Essential hypertensive patients
1. If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP \< 200 mmHg
2. If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP \< 200 mmHg
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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Hyunhee Na, MD
Role: STUDY_DIRECTOR
Yuhan Corporation
Locations
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Yuhan
Seoul, , South Korea
Countries
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Other Identifiers
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YH22162-301
Identifier Type: -
Identifier Source: org_study_id
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