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Completed

NCT Number: NCT02620163

Efficacy & Safety Study of YH22162 vs Telmisartan/Amlodipine in Patients With 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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yuhan

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent
  • Men and women ≥ 19 years of age
  • Essential hypertensive patients
  • If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP < 200 mmHg
  • 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

Treatment and study plan

telmisartan/amlodipine 40/5mg

Drug

Other names: Twynsta 40/5 mg

YH22162 40/5/12.5 mg

Drug

Other names: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg

telmisartan/amlodipine 80/5mg

Drug

Other names: Twynsta 80/5 mg

YH22162 80/5/25 mg

Drug

Other names: telmisartan/amlodipine/chlorthalidone 80/5/25 mg

telmisartan/amlodipine 40/5mg placebo

Drug

Other names: Twynsta 40/5 mg placebo

YH22162 40/5/12.5 mg placebo

Drug

Other names: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg placebo

telmisartan/amlodipine 80/5mg placebo

Drug

Other names: Twynsta 80/5 mg

YH22162 80/5/25 mg placebo

Drug

Other names: telmisartan/amlodipine/chlorthalidone 80/5/25 mg placebo

Primary outcomes

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

    Time frame: baseline and week 8

Secondary outcomes

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

    Time frame: baseline and week 2

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

    Time frame: baseline and week 4

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

    Time frame: baseline and week 2

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

    Time frame: baseline and week 4

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

    Time frame: baseline and week 8

  6. Patients Achieving Blood Pressure Control at Week 2

    Time frame: baseline and week 2

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

  7. Patients Achieving Blood Pressure Control at Week 4

    Time frame: baseline and week 4

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

  8. Patients Achieving Blood Pressure Control at Week 8

    Time frame: baseline and week 8

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

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

    Time frame: baseline and week 2

    reduction of MSSBP>= 20 mmHg and reduction of MSSBP>= 10 mmHg

  10. Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 4

    Time frame: baseline and week 4

    reduction of MSSBP>= 20 mmHg and reduction of MSSBP>= 10 mmHg

  11. Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 8

    Time frame: baseline and week 8

    reduction of MSSBP>= 20 mmHg and reduction of MSSBP>= 10 mmHg

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2015
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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