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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: YH22162 40/5/12.5 mg; 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 placebo; Drug: YH22162 80/5/25 mg placebo

• Study Type: Interventional
• Enrollment (Actual): 381
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yuhan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YH22162; 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	Drug: YH22162 40/5/12.5 mg; Other Names: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg; Drug: YH22162 80/5/25 mg; Other Names: telmisartan/amlodipine/chlorthalidone 80/5/25 mg; Drug: telmisartan/amlodipine 40/5mg placebo; Other Names: Twynsta 40/5 mg placebo; Drug: telmisartan/amlodipine 80/5mg placebo; Other Names: Twynsta 80/5 mg
Active Comparator: telmisartan/amlodipine; Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks	Drug: telmisartan/amlodipine 40/5mg; Other Names: Twynsta 40/5 mg; Drug: telmisartan/amlodipine 80/5mg; Other Names: Twynsta 80/5 mg; Drug: YH22162 40/5/12.5 mg placebo; Other Names: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg placebo; Drug: YH22162 80/5/25 mg placebo; Other Names: telmisartan/amlodipine/chlorthalidone 80/5/25 mg placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Study Director: Hyunhee Na, MD, Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 28, 2015
• First Submitted That Met QC Criteria: November 29, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Amlodipine; Chlorthalidone; Telmisartan; Telmisartan amlodipine combination
• Other Study ID Numbers: YH22162-301