Overview

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

Status:
Completed
Trial end date:
2016-09-08
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dong-A ST Co., Ltd.
Treatments:
Amlodipine
Hydrochlorothiazide
Valsartan
Criteria
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