A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])

Phase 2

Completed

• Conditions: Cardiac Edema (CHF)
• Interventions: Drug: OPC 131461 2mg group; Drug: OPC 131461 5mg group; Drug: Placebo; Drug: OPC 131461 10mg group; Drug: OPC 131461 1mg group

• Registration Number: NCT05615363
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics other than vasopressin antagonists

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Study Start: 2023-01-10
• Status Verified: 2024-10
• Primary Completion: 2024-10-21
• Study Completion: 2024-10-21
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload.

• Subjects undergoing any of the following diuretic therapies

  • Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule
  • Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses
  • Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses

• Subjects who were currently hospitalized or who are able to be hospitalized

Exclusion Criteria

• Subjects with acute heart failure
• Subjects with an assisted circulation device
• Subjects who cannot sense thirst or who have difficulty in ingesting water

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPC 131461 2mg group	OPC 131461 2mg group	OPC-131461 1 mg tablet ｘ 2
OPC 131461 5mg group	OPC 131461 5mg group	OPC-131461 5 mg tablet and placebo tablet
Placebo	Placebo	Placebo tablet
OPC 131461 10mg group	OPC 131461 10mg group	OPC-131461 5 mg tablet ｘ 2
OPC 131461 1mg group	OPC 131461 1mg group	OPC-131461 1 mg tablet and placebo tablet

Primary Outcome Measures

Name	Time	Method
Change in body weight from baseline to last assessment time point (the day after investigational medicinal product [IMP] administration) by Day 8	From baseline (before IMP administration on Day 1) to last assessment time point (the day after IMP administration) by Day 8	The primary endpoint is the change in body weight from baseline (before IMP administration on Day 1) to last assessment time point (the day after IMP administration) by Day 8.

Trial Locations

Locations (1)

Harasanshin Hospital; 🇯🇵 Fukuoka, Japan