NCT02620163

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 28, 2015

Last Update Submit

November 10, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

    baseline and week 8

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

YH22162

EXPERIMENTAL

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 mgDrug: YH22162 80/5/25 mgDrug: telmisartan/amlodipine 40/5mg placeboDrug: telmisartan/amlodipine 80/5mg placebo

telmisartan/amlodipine

ACTIVE COMPARATOR

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 40/5mgDrug: telmisartan/amlodipine 80/5mgDrug: YH22162 40/5/12.5 mg placeboDrug: YH22162 80/5/25 mg placebo

Interventions

telmisartan/amlodipine 40/5mgDRUG
Also known as: Twynsta 40/5 mg
telmisartan/amlodipine
YH22162 40/5/12.5 mgDRUG
Also known as: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg
YH22162
telmisartan/amlodipine 80/5mgDRUG
Also known as: Twynsta 80/5 mg
telmisartan/amlodipine
YH22162 80/5/25 mgDRUG
Also known as: telmisartan/amlodipine/chlorthalidone 80/5/25 mg
YH22162
telmisartan/amlodipine 40/5mg placeboDRUG
Also known as: Twynsta 40/5 mg placebo
YH22162
YH22162 40/5/12.5 mg placeboDRUG
Also known as: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg placebo
telmisartan/amlodipine
telmisartan/amlodipine 80/5mg placeboDRUG
Also known as: Twynsta 80/5 mg
YH22162
YH22162 80/5/25 mg placeboDRUG
Also known as: telmisartan/amlodipine/chlorthalidone 80/5/25 mg placebo
telmisartan/amlodipine

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with known or suspected secondary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuhan

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

TelmisartanAmlodipinetelmisartan amlodipine combinationChlorthalidone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingBenzenesulfonamidesSulfonamidesAmidesBenzophenonesPhthalimidesImidesKetonesSulfonesSulfur CompoundsIsoindoles

Study Officials

  • Hyunhee Na, MD

    Yuhan Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2015

First Posted

December 2, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations

KR(1)