The Efficacy and Safety of OROSARTAN® Versus CODIOVAN® in Patients With Essential Hypertension Uncontrolled With Monotherapy

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: OROSARTAN® 5/160mg; Drug: CODIOVAN® 160/12.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02433119

ORT_EH_IV

Details and patient eligibility

About

A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy

Enrollment: 238 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 19 aged or over
• A patient who was diagnosed with essential hypertension at screening(Visit 1)
• A patient understood objective of this clinical trial and gave their written informed consent voluntarily

Exclusion criteria

• A patient with severe hypertension(MSSBP≥200mmHg or MSDBP≥120mmHg) at Visit 1
• A subject with difference(as MSSBP≥20mmHg or MSDBP≥10mmHg) in blood pressure between right and left arm at screening evaluation
• Medical history or evidence of a secondary form of hypertension
• A subject with history of hypersensitivity to CCB(Calcium Channel Blocker), ARB(Angiotensin II Receptor Blocker) or sulfonamide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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238 participants in 2 patient groups

Amlodipine orotate & Valsartan

Experimental group

Description:

Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks

Treatment:

Drug: OROSARTAN® 5/160mg

Valsartan & Hydrochlorothiazide

Active Comparator group

Description:

Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks

Treatment:

Drug: CODIOVAN® 160/12.5mg