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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: telmisartan/amlodipine 40/5mg; Drug: YH22162 40/5/12.5 mg; Drug: YH22162 80/5/25 mg; Drug: telmisartan/amlodipine 80/5mg; Drug: telmisartan/amlodipine 40/5mg placebo; Drug: YH22162 40/5/12.5 mg placebo; Drug: telmisartan/amlodipine 80/5mg placebo; Drug: YH22162 80/5/25 mg placebo

• Registration Number: NCT02620163
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-28
• Study First Submitted QC: 2015-11-29
• Study Start: 2015-12
• Study First Posted: 2015-12-02
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YH22162	telmisartan/amlodipine 40/5mg placebo	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
telmisartan/amlodipine	telmisartan/amlodipine 40/5mg	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	YH22162 40/5/12.5 mg placebo	Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks
YH22162	YH22162 40/5/12.5 mg	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	YH22162 80/5/25 mg	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	telmisartan/amlodipine 80/5mg placebo	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
telmisartan/amlodipine	telmisartan/amlodipine 80/5mg	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	YH22162 80/5/25 mg placebo	Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8	baseline and week 8

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4	baseline and week 4
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2	baseline and week 2
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 8	baseline and week 8
Patients Achieving Blood Pressure Control at Week 4	baseline and week 4	Mean sitting blood pressure(MSBP) \< 140/90 mmHg
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 2	baseline and week 2
Patients Achieving Blood Pressure Control at Week 8	baseline and week 8	Mean sitting blood pressure(MSBP) \< 140/90 mmHg
Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 4	baseline and week 4	reduction of MSSBP\>= 20 mmHg and reduction of MSSBP\>= 10 mmHg
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 4	baseline and week 4
Patients Achieving Blood Pressure Control at Week 2	baseline and week 2	Mean sitting blood pressure(MSBP) \< 140/90 mmHg
Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 8	baseline and week 8	reduction of MSSBP\>= 20 mmHg and reduction of MSSBP\>= 10 mmHg
Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 2	baseline and week 2	reduction of MSSBP\>= 20 mmHg and reduction of MSSBP\>= 10 mmHg

Trial Locations

Locations (1)

Yuhan; 🇰🇷 Seoul, Korea, Republic of