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

NCT03772041 | Completed Phase 3 Results

• 2 other identifiers: 263-102-00003JapicCTI-184234
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Body Weight

  Change in body weight from baseline (before investigational medicinal product \[IMP\] administration on Day 1) at time of final IMP administration (day after final IMP administration). A negative change from baseline indicates improvement.

  Baseline, Day 6

Secondary Outcomes (4)

• Improvement Rate for Lower Limb Edema and Pulmonary Congestion

  Baseline, Day 6

• Change From Baseline in Jugular Venous Distension and Hepatomegaly

  Baseline, Day 6

• Percentage of Subjects Who Achieve Resolution of Pulmonary Rales and Third Cardiac Sound

  Baseline, Day 6

• Improvement Rate for New York Heart Association (NYHA) Classification

  Baseline, Day 6

Study Arms (2)

OPC-61815 injection 16 mg

EXPERIMENTAL

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

Drug: OPC-61815

Tolvaptan tablet 15mg

ACTIVE COMPARATOR

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

Drug: Tolvaptan Tab 15 MG

Interventions

OPC-61815 DRUG

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

OPC-61815 injection 16 mg

Tolvaptan Tab 15 MG DRUG

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

Tolvaptan tablet 15mg

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Saiseikai Kumamoto Hospital

Kumamoto, Japan

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Osamu Sato

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 11, 2018
• Study Start: January 16, 2019
• Primary Completion: July 21, 2020
• Study Completion: July 29, 2020
• Last Updated: August 5, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to https://clinical-trials.otsuka.com/contact-us

Locations

JP (1)