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

Phase 3CompletedNCT02620163

Yuhan Corporation381 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

381

Conditions

Hypertension

Interventions

telmisartan/amlodipine 40/5mgDRUG

YH22162 40/5/12.5 mgDRUG

telmisartan/amlodipine 80/5mgDRUG

YH22162 80/5/25 mgDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Yuhan

Seoul, South Korea

Outcomes

Primary Outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8

Time frame: baseline and week 8

Secondary Outcomes

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2

Time frame: baseline and week 2

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4

Time frame: baseline and week 4

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 2

Time frame: baseline and week 2

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 4

Time frame: baseline and week 4

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 8

Time frame: baseline and week 8

Patients Achieving Blood Pressure Control at Week 2

Mean sitting blood pressure(MSBP) \< 140/90 mmHg

Time frame: baseline and week 2

Patients Achieving Blood Pressure Control at Week 4

Mean sitting blood pressure(MSBP) \< 140/90 mmHg

Time frame: baseline and week 4

Patients Achieving Blood Pressure Control at Week 8

Mean sitting blood pressure(MSBP) \< 140/90 mmHg

Time frame: baseline and week 8

Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 2

Data from ClinicalTrials.gov

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