NCT02331680 is a Phase 2 clinical trial of OPC-41061 in Chronic Renal Failure, sponsored by Otsuka Pharmaceutical Co., Ltd..

Who is sponsoring NCT02331680?

NCT02331680 is sponsored by Otsuka Pharmaceutical Co., Ltd..

What drugs are being tested in NCT02331680?

Interventions in NCT02331680: OPC-41061, OPC-41061, Placebo.

What condition does NCT02331680 study?

NCT02331680 studies Chronic Renal Failure.

Is NCT02331680 still recruiting?

NCT02331680 is currently completed. Last updated 2 October 2019.

Are results published for NCT02331680?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-10-02 · How we verify

NCT02331680

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

A Phase 2, Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration

Completed Phase 2 Results posted Last updated 2 October 2019

What this trial tests

Phase 2 trial testing OPC-41061 in Chronic Renal Failure in 124 participants. Completed in 1 May 2016.

Timeline

1 December 2014

Primary endpoint
1 May 2016

1 May 2016

Quick facts

Lead sponsor	Otsuka Pharmaceutical Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	124
Start date	1 December 2014
Primary completion	1 May 2016
Estimated completion	1 May 2016
Sites	4 locations across Japan

Drugs / interventions tested

OPC-41061 — full drug profile →
OPC-41061 — full drug profile →
Placebo

Conditions studied

Chronic Renal Failure — all drugs for Chronic Renal Failure →

Sponsor

Otsuka Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 20 to 80, any sex, with Chronic Renal Failure. 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.

Change From Baseline in Daily Urine Volume
Time frame: Baseline，End of the treatment
Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.

Sponsor's own description

This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.

Publications & conference data

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

Novel Approaches in Chronic Renal Failure without Renal Replacement Therapy: A Review.
Martínez-Hernández SL, Muñoz-Ortega MH, Ávila-Blanco ME, Medina-Pizaño MY, et al · · 2023 · cited 10× · PMID 37893201 · DOI 10.3390/biomedicines11102828
Efficacy and safety of oral tolvaptan in patients undergoing hemodialysis: a Phase 2, double-blind, randomized, placebo-controlled trial.
Ogata H, Shimofurutani N, Okada T, Nagamoto H, et al · · 2021 · cited 2× · PMID 32901255 · DOI 10.1093/ndt/gfaa148

Verify or expand the search:

Other trials of OPC-41061

Trials testing the same drug.

NCT02994394 — A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy · Phase 1 · completed

Other recruiting trials for Chronic Renal Failure

Currently open trials in the same condition.

NCT06227468 — A Clinical Study to Map the HLA Genomic Region in the Greek Population · recruiting
NCT06347029 — Evaluation of Endothelial Dysfunction Using the "Flow Mediated Dilation" Test in a Population of Chronic Renal Failure P · NA · recruiting
NCT05884866 — A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone, Compared to B · Phase 2 · recruiting
NCT05353946 — Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure · NA · recruiting

Other Otsuka Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07053891 — LUPKYNIS Drug-use Results Survey · recruiting
NCT06875986 — REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapi · recruiting
NCT06036108 — Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia · Phase 1 · completed
NCT05712746 — Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure. · recruiting
NCT05687071 — A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia · Phase 3 · 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 NCT02331680 (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 Otsuka Pharmaceutical Co., Ltd.
Last refreshed: 2 October 2019

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/NCT02331680.

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