Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

NCT ID: NCT03255226

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2021-07-15

Brief Summary

To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload

Conditions

Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tolvaptan

Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.

Group Type: EXPERIMENTAL

Tolvaptan

Intervention Type: DRUG

Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.

Interventions

Tolvaptan

Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with volume overload despite having received any of the following diuretic therapies in whom sufficient effects cannot be expected even if the dose of the diuretics is increased or in whom the investigator or subinvestigator judges that increasing the dose of the diuretics is difficult due to concerns regarding electrolyte abnormalities or other side effects

• Furosemide (oral administration) ≥0.5 mg/kg/day. Azosemide 30 mg and torasemide 4 mg will be calculated as equivalent to furosemide 20 mg.
• Hydrochlorothiazide ≥2 mg/kg/day
• Trichlormethiazide ≥0.05 mg/kg/day
• Spironolactone ≥ 1 mg/kg/day
• Patients capable of complaining of thirst. Patients unable to complain of thirst due to their young age can also be enrolled in the trial if strict management of fluid intake and excretion is conducted. However, even if such fluid management is possible, the patients in whom the investigator or subinvestigator judges that tolvaptan cannot be safely administered are to be excluded
• Patients who can be hospitalized from at least 3 days before start of tolvaptan administration until 2 days after the final administration.

others

Exclusion Criteria

• Patients whose volume overload status shows improvement during the screening period or pretreatment observation period
• Patients who are unable to drink fluid (including patients who are unable to sense thirst)
• Patients whose circulatory blood flow is suspected to be decreased
• Patients with an assisted circulation apparatus
• Patients with hypernatremia (serum or blood sodium concentration exceeding 145 mEq/L) others

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takehisa Matsumaru, Mr

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Kanto Region, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JapicCTI-173674

Identifier Type: OTHER

Identifier Source: secondary_id

156-102-00123

Identifier Type: -

Identifier Source: org_study_id