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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02294539
Enrollment
231
Registered
2014-11-19
Start date
2014-08-31
Completion date
2016-05-18
Last updated
2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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

Interventions

DRUGLosartan 50mg/amlodipine 5mg

once daily, 1T, PO medication

DRUGLosartan 100mg/amlodipine 5mg

once daily, 1T, PO medication

DRUGLosartan 50mg/Hydrochlorothiazide 12.5mg

once daily, 1T, PO medication

DRUGLosartan 100mg/Hydrochlorothiazide 25mg

once daily, 1T, PO medication

Sponsors

Hanmi Pharmaceutical Company Limited
CollaboratorINDUSTRY
Chong-Jin Kim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Hypertension patients not included

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
change from baseline in msSBP4 weeks

Secondary

MeasureTime frame
change from baseline in AMcSBP20 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026