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

Chong-Jin Kim

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Losartan 100mg/Hydrochlorothiazide 25mg; Drug: Losartan 100mg/amlodipine 5mg; Drug: Losartan 50mg/Hydrochlorothiazide 12.5mg; Drug: Losartan 50mg/amlodipine 5mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02294539

KSH_AMST

Details and patient eligibility

About

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

Enrollment: 231 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 4 patient groups

Losartan 50mg/amlodipine 5mg

Experimental group

Description:

Once daily, 1T, PO medication

Treatment:

Drug: Losartan 50mg/Hydrochlorothiazide 12.5mg

Losartan 100mg/amlodipine 5mg

Experimental group

Description:

Once daily, 1T, PO medication

Treatment:

Drug: Losartan 100mg/Hydrochlorothiazide 25mg

Losartan50 mg/Hydrochlorothiazide12.5 mg

Active Comparator group

Description:

Once daily, 1T, PO medication

Treatment:

Drug: Losartan 50mg/amlodipine 5mg

Losartan100 mg/Hydrochlorothiazide25 mg

Active Comparator group

Description:

Once daily, 1T, PO medication

Treatment:

Drug: Losartan 100mg/amlodipine 5mg