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A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH22162 in Subjects With Essential Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment
To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment
Details
| Lead sponsor | Yuhan Corporation |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 381 |
| Start date | 2015-12 |
| Completion | 2016-12 |
Conditions
- Hypertension
Interventions
- 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
Primary outcomes
- Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 — baseline and week 8
Countries
South Korea