Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223620

Enrollment

Registered

2017-08-21

Start date

2017-11-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive heart failure

Interventions

investigational material(s) Generic name etc : OPC-61815 INN of investigational material : Tolvaptan Therapeutic category code : 213 Diuretics Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects who are currently on treatment with any of the following diuretics - Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher - Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose - Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose 2. Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present 3. Subjects who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion criteria

Exclusion criteria: 1. Subjects with acute heart failure 2. Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan 3. Subjects who are unable to sense thirst or who have difficulty with fluid intake

Design outcomes

Primary

Measure	Time frame
pharmacokinetics Tolvaptan exposure	—

Secondary

Measure	Time frame
safety efficacy pharmacodynamics Adverse Event	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026