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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: OROSARTAN® 5/160mg; Drug: CODIOVAN® 160/12.5mg

• Registration Number: NCT02433119
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-16
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-04
• Primary Completion: 2016-09-08
• Study Completion: 2016-09-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine orotate & Valsartan	OROSARTAN® 5/160mg	Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks
Valsartan & Hydrochlorothiazide	CODIOVAN® 160/12.5mg	Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline, Week 8

Secondary Outcome Measures

Name	Time	Method
Responder rate in blood pressure	Baseline, Week 8	Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline
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	Rate of patients who achieved target blood pressure(MSDBP\<90mmHg and MSSBP\<140mmHg)

Trial Locations

Locations (1)

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of