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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Cardiac Edema (CHF)

Treatments: Drug: Placebo; Drug: OPC 131461 1mg group; Drug: OPC 131461 10mg group; Drug: OPC 131461 2mg group; Drug: OPC 131461 5mg group

Study type: Interventional

Funder types: Industry

Identifiers

NCT05615363

jRCT (Registry Identifier)

351-102-00004

Details and patient eligibility

About

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

Enrollment: 157 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 5 patient groups, including a placebo group

OPC 131461 10mg group

Experimental group

Description:

OPC-131461 5 mg tablet ｘ 2

Treatment:

Drug: OPC 131461 10mg group

OPC 131461 5mg group

Experimental group

Description:

OPC-131461 5 mg tablet and placebo tablet

Treatment:

Drug: OPC 131461 5mg group

OPC 131461 2mg group

Experimental group

Description:

OPC-131461 1 mg tablet ｘ 2

Treatment:

Drug: OPC 131461 2mg group

OPC 131461 1mg group

Experimental group

Description:

OPC-131461 1 mg tablet and placebo tablet

Treatment:

Drug: OPC 131461 1mg group

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo