NCT01838850 is a Phase 3 clinical trial of CS8635 20/5/12.5mg and placebo in Essential Hypertension, sponsored by Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company.

Who is sponsoring NCT01838850?

NCT01838850 is sponsored by Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company.

What drugs are being tested in NCT01838850?

Interventions in NCT01838850: CS8635 20/5/12.5mg and placebo, Olmetec® Plus 20/12.5mg and placebo.

What condition does NCT01838850 study?

NCT01838850 studies Essential Hypertension.

Is NCT01838850 still recruiting?

NCT01838850 is currently completed. Last updated 20 December 2018.

Last reviewed 2018-12-20 · How we verify

NCT01838850

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

A Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Triple Fixed Dose Combination Therapy With Olmesartan Medoxomil 20mg, Amlodipine 5mg and Hydrochlorothiazide 12.5mg in Patients With Hypertension Not Controlled With Dual Fixed Dose Combination Therapy With Olmesartan Medoxomil 20mg and Hydrochlorothiazide 12.5mg

Completed Phase 3 Last updated 20 December 2018

What this trial tests

Phase 3 trial testing CS8635 20/5/12.5mg and placebo in Essential Hypertension in 344 participants. Completed in 1 August 2014.

Timeline

1 April 2013

Primary endpoint
1 August 2014

1 August 2014

Quick facts

Lead sponsor	Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	344
Start date	1 April 2013
Primary completion	1 August 2014
Estimated completion	1 August 2014
Sites	39 locations across South Korea

Drugs / interventions tested

CS8635 20/5/12.5mg and placebo — full drug profile →
Olmetec® Plus 20/12.5mg and placebo — full drug profile →

Conditions studied

Essential Hypertension — all drugs for Essential Hypertension →

Sponsor

Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company — full company profile →

Who can join

Adults 20 to 75, any sex, with Essential Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The changes of seated diastolic blood pressure of the Triple Combinations OM/AML/HCTZ 20/5/12.5mg vs.OM/HCTZ 20/12.5mg
Time frame: from baseline to week 8

Sponsor's own description

CS-8635 combines three widely prescribed antihypertensive medications, olmesartan medoxomil(OM), amlodipine (AML), and hydrochlorothiazide (HCTZ), to lower blood pressure. The purpose of the study is to evaluate the efficacy and safety of triple therapy with CS-8635 compared with dual therapy in Korean patients with hypertension not controlled with dual fixed dose combination therapy (Olmetec® Plus). The treatments that will be used in this study are as follows: Run-in period -OM/HCTZ 20/12.5 mg (Olmetec® Plus 20/12.5 mg) ; Double blind treatment period - OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg) + its matching placebo vs.OM/HCTZ 20/12.5mg (Olmetec® Plus 20/12.5 mg) + its matching placebo; Open label extension period - OM/AML/HCTZ 40/5/12.5mg (CS8635 40/5/12.5mg) or OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Combination Therapy in Patients with Hypertension Not Controlled with Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy: Results of a Randomized, Double-Blind, Multicenter Trial.
Sohn IS, Kim CJ, Oh BH, Hong TJ, et al · · 2016 · cited 4× · PMID 26691333 · DOI 10.1007/s40256-015-0156-x
Improving computational drug repositioning through multi-source disease similarity networks.
Le DH. · · 2025 · cited 1× · PMID 40841559 · DOI 10.1038/s41598-025-04772-0

Verify or expand the search:

Other recruiting trials for Essential Hypertension

Currently open trials in the same condition.

NCT07282145 — Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers · Phase 1 · recruiting
NCT06778239 — Childhood-Onset Essential Hypertension Natural History Study · recruiting
NCT07051811 — To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension · NA · recruiting
NCT06643819 — Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A · Phase 3 · recruiting
NCT05880056 — Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian P · Phase 4 · recruiting

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 NCT01838850 (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 Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company
Last refreshed: 20 December 2018

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/NCT01838850.

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