HypertensionPhase 4NCT02294539

Comparison of Effects Between Amlodipine and Hydrochlorothiazide in Combination With Losartan on 24-hr Central Blood Pressure in Hypertensive Patients

A Phase 4 study testing Losartan 50mg/amlodipine 5mg, Losartan 100mg/amlodipine 5mg and Losartan 50mg/Hydrochlorothiazide 12.5mg in people with Hypertension, run by Chong-Jin Kim 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

The purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (BP) and AM central SBP in hypertensive patients:Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics Read more about this study

Who is it for?: Ages 19 to 80 years
Conditions the study is for: Hypertension
What is being tested?: Losartan 50mg/amlodipine 5mg, Losartan 100mg/amlodipine 5mg and Losartan 50mg/Hydrochlorothiazide 12.5mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 231 participants
Where: 1 siteSouth Korea
Study dates: Aug 2014to 18 May 2016
Phase: Phase 4
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hypertension patients not included exclusion criteria
Mean seated SBP ≥140mmHg in patients with newly Diagnosed

Who cannot join

msDBP≥110mmHg or ms SBP ≥ 180mmHg at the screening and randomization visit

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Kyung Hee University Hospital at Gangdong
Seoul

Other trials in South Korea

About this study

Official title: Comparison of Effects Between Calcium Channel Blocker and Diuretics in Combination With Angiotensin II Receptor Blocker on 24-hr Central Blood Pressure and Vascular Hemodynamic Parameters in Hypertensive Patients Multicenter, Double-blind, Active-controlled, Phase 4 Randomized Trial

Conditions: Hypertension
Being tested: Losartan 50mg/amlodipine 5mg, Losartan 100mg/amlodipine 5mg, Losartan 50mg/Hydrochlorothiazide 12.5mg, Losartan 100mg/Hydrochlorothiazide 25mg
Medical subject headings: Hypertension

What participants receive

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

Losartan 50mg/amlodipine 5mgDrug
Also called amosartan 5/50mg
once daily, 1T, PO medication
Losartan 100mg/amlodipine 5mgDrug
Also called amosartan 5/100mg
once daily, 1T, PO medication
Losartan 50mg/Hydrochlorothiazide 12.5mgDrug
Also called Cozaar Plus
once daily, 1T, PO medication
Losartan 100mg/Hydrochlorothiazide 25mgDrug
Also called Cozaar Plus F
once daily, 1T, PO medication

Study groups in NCT02294539
Study group	Role	What they receive
Losartan 50mg/amlodipine 5mg	Experimental	Once daily, 1T, PO medication Receives: Drug: Losartan 50mg/Hydrochlorothiazide 12.5mg
Losartan 100mg/amlodipine 5mg	Experimental	Once daily, 1T, PO medication Receives: Drug: Losartan 100mg/Hydrochlorothiazide 25mg
Losartan50 mg/Hydrochlorothiazide12.5 mg	Active comparator	Once daily, 1T, PO medication Receives: Drug: Losartan 50mg/amlodipine 5mg
Losartan100 mg/Hydrochlorothiazide25 mg	Active comparator	Once daily, 1T, PO medication Receives: Drug: Losartan 100mg/amlodipine 5mg

What is being measured

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

change from baseline in msSBP
Measured: 4 weeks

Secondary outcomes (1)

change from baseline in AMcSBP
Measured: 20 weeks

Timeline

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

Aug 201418 May 2016

First posted19 Nov 2014 (estimated)
Study startAug 2014
Primary completion18 May 2016
Study completion18 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 231 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02294539
Sponsor's protocol ID: KSH_AMST
Status last verified: Mar 2017
First submitted: 12 Nov 2014
Last updated: 15 Mar 2017
Results posted: No
Data monitoring committee: No

Publications

Cho EJ, Lee HY, Sung KC, Park S, Sohn IS, Park CG, Choi DJ, Ha JW, Ahn YK, Shin J, Hong SJ, Kim SK, Chung WJ, Yoo BS, Hong TJ, Youn HJ, Cho MC, Chae SC, Kim YJ, Kim CJ. Comparison of 24-Hour Ambulatory Central Blood Pressure Reduction Efficacy Between Fixed Amlodipine or Up-Titrated Hydrochlorothiazide Plus Losartan: The K-Central Study. Am J Hypertens. 2019 Sep 24;32(10):992-1002. doi: 10.1093/ajh/hpz050.
PubMed 31099387
Oh GC, Lee HY, Chung WJ, Youn HJ, Cho EJ, Sung KC, Chae SC, Yoo BS, Park CG, Hong SJ, Kim YK, Hong TJ, Choi DJ, Hyun MS, Ha JW, Kim YJ, Ahn Y, Cho MC, Kim SG, Shin J, Park S, Sohn IS, Kim CJ. Comparison of effects between calcium channel blocker and diuretics in combination with angiotensin II receptor blocker on 24-h central blood pressure and vascular hemodynamic parameters in hypertensive patients: study design for a multicenter, double-blinded, active-controlled, phase 4, randomized trial. Clin Hypertens. 2017 Sep 4;23:18. doi: 10.1186/s40885-017-0074-0. eCollection 2017.
PubMed 28879040

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Effects Between Calcium Channel Blocker and Diuretics in Combination With Angiotensin II Receptor Blocker on 24-hr Central Blood Pressure and Vascular Hemodynamic Parameters in Hypertensive Patients Multicenter, Double-blind, Active-controlled, Phase 4 Randomized Trial
ClinicalTrials.gov ID: NCT02294539
Acronym / sponsor ID: KSH_AMST
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 231 participants (actual)
Lead sponsor: Chong-Jin KimUniversity, hospital or other
Collaborators: Hanmi Pharmaceutical Company Limited
Study start: Aug 2014
Primary completion: 18 May 2016 (actual)
Study completion: 18 May 2016 (actual)
First posted: 19 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Losartan 50mg/amlodipine 5mg	Experimental	Drug: Losartan 50mg/Hydrochlorothiazide 12.5mgOnce daily, 1T, PO medication
Losartan 100mg/amlodipine 5mg	Experimental	Drug: Losartan 100mg/Hydrochlorothiazide 25mgOnce daily, 1T, PO medication
Losartan50 mg/Hydrochlorothiazide12.5 mg	Active comparator	Drug: Losartan 50mg/amlodipine 5mgOnce daily, 1T, PO medication
Losartan100 mg/Hydrochlorothiazide25 mg	Active comparator	Drug: Losartan 100mg/amlodipine 5mgOnce daily, 1T, PO medication

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Hypertension patients not included exclusion criteria
Mean seated SBP ≥140mmHg in patients with newly Diagnosed

Key exclusion criteria (1 listed)

msDBP≥110mmHg or ms SBP ≥ 180mmHg at the screening and randomization visit

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Losartan 50mg/amlodipine 5mgAlso: amosartan 5/50mgonce daily, 1T, PO medication	Drug	Losartan50 mg/Hydrochlorothiazide12.5 mg
Losartan 100mg/amlodipine 5mgAlso: amosartan 5/100mgonce daily, 1T, PO medication	Drug	Losartan100 mg/Hydrochlorothiazide25 mg
Losartan 50mg/Hydrochlorothiazide 12.5mgAlso: Cozaar Plusonce daily, 1T, PO medication	Drug	Losartan 50mg/amlodipine 5mg
Losartan 100mg/Hydrochlorothiazide 25mgAlso: Cozaar Plus Fonce daily, 1T, PO medication	Drug	Losartan 100mg/amlodipine 5mg

Primary outcome

change from baseline in msSBP
Time frame: 4 weeks

1 secondary outcome

change from baseline in AMcSBP
Time frame: 20 weeks

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
Derived from this study: PubMed 31099387Cho EJ, Lee HY, Sung KC, Park S, Sohn IS, Park CG, Choi DJ, Ha JW, Ahn YK, Shin J, Hong SJ, Kim SK, Chung WJ, Yoo BS, Hong TJ, Youn HJ, Cho MC, Chae SC, Kim YJ, Kim CJ. Comparison of 24-Hour Ambulatory Central Blood Pressure Reduction Efficacy Between Fixed Amlodipine or Up-Titrated Hydrochlorothiazide Plus Losartan: The K-Central Study. Am J Hypertens. 2019 Sep 24;32(10):992-1002. doi: 10.1093/ajh/hpz050.
Derived from this study: PubMed 28879040Oh GC, Lee HY, Chung WJ, Youn HJ, Cho EJ, Sung KC, Chae SC, Yoo BS, Park CG, Hong SJ, Kim YK, Hong TJ, Choi DJ, Hyun MS, Ha JW, Kim YJ, Ahn Y, Cho MC, Kim SG, Shin J, Park S, Sohn IS, Kim CJ. Comparison of effects between calcium channel blocker and diuretics in combination with angiotensin II receptor blocker on 24-h central blood pressure and vascular hemodynamic parameters in hypertensive patients: study design for a multicenter, double-blinded, active-controlled, phase 4, randomized trial. Clin Hypertens. 2017 Sep 4;23:18. doi: 10.1186/s40885-017-0074-0. eCollection 2017.

Related trials for Hypertension

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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chong-Jin Kim principal investigator

Kyung Hee University Hospital at Gangdong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 1 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 15 Mar 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 msSBP (time frame: 4 weeks). 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 NCT02294539, which also lists 2 linked publications.

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 15 Mar 2017.