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HypertensionPhase 3NCT02620163

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

A Phase 3 study testing telmisartan/amlodipine 40/5mg, YH22162 40/5/12.5 mg and telmisartan/amlodipine 80/5mg in people with Hypertension, run by Yuhan Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hypertension
What is being tested?
telmisartan/amlodipine 40/5mg, YH22162 40/5/12.5 mg and telmisartan/amlodipine 80/5mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
381 participants
Where
1 siteSouth Korea
Study dates
Dec 2015to Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients with known or suspected secondary hypertension
  • Other exclusions applied

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yuhan

    Seoul

Other trials in South Korea

About this study

Official 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

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

Conditions
Hypertension
Being tested
telmisartan/amlodipine 40/5mg, YH22162 40/5/12.5 mg, telmisartan/amlodipine 80/5mg, YH22162 80/5/25 mg, telmisartan/amlodipine 40/5mg placebo
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telmisartan/amlodipine 40/5mgDrug

    Also called Twynsta 40/5 mg

  • YH22162 40/5/12.5 mgDrug

    Also called telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg

  • telmisartan/amlodipine 80/5mgDrug

    Also called Twynsta 80/5 mg

  • YH22162 80/5/25 mgDrug

    Also called telmisartan/amlodipine/chlorthalidone 80/5/25 mg

  • telmisartan/amlodipine 40/5mg placeboDrug

    Also called Twynsta 40/5 mg placebo

  • YH22162 40/5/12.5 mg placeboDrug

    Also called telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg placebo

  • telmisartan/amlodipine 80/5mg placeboDrug

    Also called Twynsta 80/5 mg

  • YH22162 80/5/25 mg placeboDrug

    Also called telmisartan/amlodipine/chlorthalidone 80/5/25 mg placebo

Study groups in NCT02620163
Study groupRoleWhat they receive
YH22162ExperimentalYH22162 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
Receives: 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
telmisartan/amlodipineActive comparatorTwynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: baseline and week 8

Secondary outcomes (11)

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

    Measured: baseline and week 2

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

    Measured: baseline and week 4

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

    Measured: baseline and week 2

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

    Measured: baseline and week 4

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

    Measured: baseline and week 8

  6. Patients Achieving Blood Pressure Control at Week 2

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

    Measured: baseline and week 2

  7. Patients Achieving Blood Pressure Control at Week 4

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

    Measured: baseline and week 4

  8. Patients Achieving Blood Pressure Control at Week 8

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

    Measured: baseline and week 8

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

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

    Measured: baseline and week 2

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

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

    Measured: baseline and week 4

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

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

    Measured: baseline and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02620163
Sponsor's protocol ID
YH22162-301
Status last verified
Nov 2024
First submitted
28 Nov 2015
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing telmisartan/amlodipine 40/5mg, YH22162 40/5/12.5 mg and telmisartan/amlodipine 80/5mg in people with Hypertension, run by Yuhan Corporation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 (time frame: baseline and week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02620163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

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