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

NCT ID: NCT02294539

Last Updated: 2017-03-15

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-05-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Losartan 50mg/amlodipine 5mg

Once daily, 1T, PO medication

Group Type EXPERIMENTAL

Losartan 50mg/Hydrochlorothiazide 12.5mg

Intervention Type DRUG

once daily, 1T, PO medication

Losartan 100mg/amlodipine 5mg

Once daily, 1T, PO medication

Group Type EXPERIMENTAL

Losartan 100mg/Hydrochlorothiazide 25mg

Intervention Type DRUG

once daily, 1T, PO medication

Losartan50 mg/Hydrochlorothiazide12.5 mg

Once daily, 1T, PO medication

Group Type ACTIVE_COMPARATOR

Losartan 50mg/amlodipine 5mg

Intervention Type DRUG

once daily, 1T, PO medication

Losartan100 mg/Hydrochlorothiazide25 mg

Once daily, 1T, PO medication

Group Type ACTIVE_COMPARATOR

Losartan 100mg/amlodipine 5mg

Intervention Type DRUG

once daily, 1T, PO medication

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Losartan 50mg/amlodipine 5mg

once daily, 1T, PO medication

Intervention Type DRUG

Losartan 100mg/amlodipine 5mg

once daily, 1T, PO medication

Intervention Type DRUG

Losartan 50mg/Hydrochlorothiazide 12.5mg

once daily, 1T, PO medication

Intervention Type DRUG

Losartan 100mg/Hydrochlorothiazide 25mg

once daily, 1T, PO medication

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

amosartan 5/50mg amosartan 5/100mg Cozaar Plus Cozaar Plus F

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* Mean seated SBP ≥140mmHg in patients with newly Diagnosed


\- msDBP≥110mmHg or ms SBP ≥ 180mmHg at the screening and randomization visit
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role collaborator

Chong-Jin Kim

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chong-Jin Kim

Chairman of Cardiovascular Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chong-Jin Kim

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital at Gangdong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31099387 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28879040 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KSH_AMST

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.