Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

NCT ID: NCT03772041

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2020-07-29

Brief Summary

To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OPC-61815 injection 16 mg

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg

Group Type: EXPERIMENTAL

OPC-61815

Intervention Type: DRUG

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg

Tolvaptan tablet 15mg

Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo

Group Type: ACTIVE_COMPARATOR

Tolvaptan Tab 15 MG

Intervention Type: DRUG

Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo

Interventions

OPC-61815

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg

Intervention Type: DRUG

Tolvaptan Tab 15 MG

Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who are currently on treatment with any of the following diuretics

1. Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher

2. Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose

3. Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose

• Patients with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
• Patients who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria

• Patients with acute heart failure
• Patients who are on a ventricular assist device
• Patients who are unable to sense thirst or who have difficulty with fluid intake

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Osamu Sato

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Saiseikai Kumamoto Hospital

Kumamoto, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JapicCTI-184234

Identifier Type: OTHER

Identifier Source: secondary_id

263-102-00003

Identifier Type: -

Identifier Source: org_study_id