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

NCT03255226 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-23

Study results available
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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

Interventions

DRUG

Tolvaptan

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takehisa Matsumaru, Mr · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2021-07-11
Completion
2021-07-15

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255226 on ClinicalTrials.gov