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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02620163

Enrollment

381

Registered

2015-12-02

Start date

2015-12-31

Completion date

2016-12-31

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

DRUGtelmisartan/amlodipine 80/5mg placebo

DRUGYH22162 80/5/25 mg placebo

DRUGtelmisartan/amlodipine 40/5mg

DRUGYH22162 40/5/12.5 mg

DRUGtelmisartan/amlodipine 80/5mg

DRUGYH22162 80/5/25 mg

DRUGtelmisartan/amlodipine 40/5mg placebo

DRUGYH22162 40/5/12.5 mg placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026