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

NCT ID: NCT02620163

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

YH22162 40/5/12.5 mg

Intervention Type DRUG

YH22162 80/5/25 mg

Intervention Type DRUG

telmisartan/amlodipine 40/5mg placebo

Intervention Type DRUG

telmisartan/amlodipine 80/5mg placebo

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

telmisartan/amlodipine 40/5mg

Intervention Type DRUG

telmisartan/amlodipine 80/5mg

Intervention Type DRUG

YH22162 40/5/12.5 mg placebo

Intervention Type DRUG

YH22162 80/5/25 mg placebo

Intervention Type DRUG

Interventions

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telmisartan/amlodipine 40/5mg

Intervention Type DRUG

YH22162 40/5/12.5 mg

Intervention Type DRUG

telmisartan/amlodipine 80/5mg

Intervention Type DRUG

YH22162 80/5/25 mg

Intervention Type DRUG

telmisartan/amlodipine 40/5mg placebo

Intervention Type DRUG

YH22162 40/5/12.5 mg placebo

Intervention Type DRUG

telmisartan/amlodipine 80/5mg placebo

Intervention Type DRUG

YH22162 80/5/25 mg placebo

Intervention Type DRUG

Other Intervention Names

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Twynsta 40/5 mg telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg Twynsta 80/5 mg telmisartan/amlodipine/chlorthalidone 80/5/25 mg Twynsta 40/5 mg placebo telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg placebo Twynsta 80/5 mg telmisartan/amlodipine/chlorthalidone 80/5/25 mg placebo

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyunhee Na, MD

Role: STUDY_DIRECTOR

Yuhan Corporation

Locations

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Yuhan

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YH22162-301

Identifier Type: -

Identifier Source: org_study_id

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