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

Dong-A ST Co., Ltd.1 site in 1 country238 target enrollmentMarch 16, 2015

ConditionsHypertension

InterventionsOROSARTAN® 5/160mg CODIOVAN® 160/12.5mg

Overview

Phase: Phase 4
Intervention: OROSARTAN® 5/160mg
Conditions: Hypertension
Sponsor: Dong-A ST Co., Ltd.
Enrollment: 238
Locations: 1
Primary Endpoint: Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

March 16, 2015

End Date

September 8, 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dong-A ST Co., Ltd.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Amlodipine orotate & Valsartan

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

Intervention: OROSARTAN® 5/160mg

Valsartan & Hydrochlorothiazide

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

Intervention: CODIOVAN® 160/12.5mg

Outcomes

Primary Outcomes

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

Time Frame: Baseline, Week 8

Secondary Outcomes

Responder rate in blood pressure(Baseline, Week 8)
Change from baseline in MSDBP(Baseline, Week 4)
Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)(Baseline, Week 4 and 8)
Control rate in blood pressure(Baseline, Week 8)