NCT02433119 is a Phase 4 clinical trial of OROSARTAN® 5/160mg in Hypertension, sponsored by Dong-A ST Co., Ltd..

Who is sponsoring NCT02433119?

NCT02433119 is sponsored by Dong-A ST Co., Ltd..

What drugs are being tested in NCT02433119?

Interventions in NCT02433119: OROSARTAN® 5/160mg, CODIOVAN® 160/12.5mg.

What condition does NCT02433119 study?

NCT02433119 studies Hypertension.

Is NCT02433119 still recruiting?

NCT02433119 is currently completed. Last updated 12 April 2017.

Last reviewed 2017-04-12 · How we verify

NCT02433119

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 12 April 2017

What this trial tests

Phase 4 trial testing OROSARTAN® 5/160mg in Hypertension in 238 participants. Completed in 8 September 2016.

Timeline

16 March 2015

Primary endpoint
8 September 2016

8 September 2016

Quick facts

Lead sponsor	Dong-A ST Co., Ltd.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	238
Start date	16 March 2015
Primary completion	8 September 2016
Estimated completion	8 September 2016
Sites	1 location across South Korea

Drugs / interventions tested

OROSARTAN® 5/160mg — full drug profile →
CODIOVAN® 160/12.5mg — full drug profile →

Conditions studied

Hypertension — all drugs for Hypertension →

Sponsor

Dong-A ST Co., Ltd. — full company profile →

Who can join

19 and older, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A multicenter, randomized, and double-blind phase IV clinical trial to compare the efficacy and safety of fixed-dose combinations of amlodipine orotate/valsartan 5/160 mg versus valsartan/hydrochlorothiazide 160/12.5 mg in patients with essential hypertension uncontrolled by vals
Ahn Y, Kim Y, Chang K, Kim W, et al · · 2018 · cited 4× · PMID 30212981 · DOI 10.1097/md.0000000000012329

Verify or expand the search:

Other recruiting trials for Hypertension

Currently open trials in the same condition.

NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A · NA · recruiting
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NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting

Other Dong-A ST Co., Ltd. trials

Trials by the same sponsor.

NCT07342062 — Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fed State · Phase 1 · completed
NCT07297940 — Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fasting State · Phase 1 · completed
NCT07027982 — A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjec · Phase 1 · completed
NCT07046715 — Clinical Trial Comparing Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 · Phase 1 · completed
NCT07007533 — A Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy A · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02433119 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dong-A ST Co., Ltd.
Last refreshed: 12 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02433119.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing