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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Congestive Heart Failure

Treatments: Drug: OPC-61815; Drug: Tolvaptan Tab 15 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT03772041

JapicCTI-184234 (Other Identifier)

263-102-00003

Details and patient eligibility

About

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

Enrollment: 294 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 2 patient groups

OPC-61815 injection 16 mg

Experimental group

Description:

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

Treatment:

Drug: OPC-61815

Tolvaptan tablet 15mg

Active Comparator group

Description:

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

Treatment:

Drug: Tolvaptan Tab 15 MG