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

Dong-A ST Co., Ltd.238 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

238

Conditions

Hypertension

Interventions

OROSARTAN® 5/160mgDRUG

CODIOVAN® 160/12.5mgDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Gachon University Gil Hospital

Incheon, South Korea

Outcomes

Primary Outcomes

Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)

Time frame: Baseline, Week 8

Secondary Outcomes

Change from baseline in MSDBP

Time frame: Baseline, Week 4

Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)

Time frame: Baseline, Week 4 and 8

Control rate in blood pressure

Rate of patients who achieved target blood pressure(MSDBP\<90mmHg and MSSBP\<140mmHg)

Time frame: Baseline, Week 8

Responder rate in blood pressure

Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline

Time frame: Baseline, Week 8

Data from ClinicalTrials.gov

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