Efficacy & Safety Study of YH22162 vs Telmisartan/Amlodipine in Patients With Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment

Yuhan

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: YH22162 40/5/12.5 mg placebo; Drug: YH22162 80/5/25 mg placebo; Drug: YH22162 80/5/25 mg; Drug: telmisartan/amlodipine 40/5mg placebo; Drug: telmisartan/amlodipine 80/5mg placebo; Drug: telmisartan/amlodipine 40/5mg; Drug: telmisartan/amlodipine 80/5mg; Drug: YH22162 40/5/12.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02620163

YH22162-301

Details and patient eligibility

About

To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment

Enrollment: 381 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed Consent

• 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

• Patients with known or suspected secondary hypertension
• Other exclusions applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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381 participants in 2 patient groups

YH22162

Experimental group

Description:

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

Treatment:

Drug: YH22162 40/5/12.5 mg

Drug: telmisartan/amlodipine 80/5mg placebo

Drug: telmisartan/amlodipine 40/5mg placebo

Drug: YH22162 80/5/25 mg

telmisartan/amlodipine

Active Comparator group

Description:

Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks

Treatment:

Drug: telmisartan/amlodipine 80/5mg

Drug: telmisartan/amlodipine 40/5mg

Drug: YH22162 80/5/25 mg placebo

Drug: YH22162 40/5/12.5 mg placebo