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

January 11, 2021 updated by: Otsuka Pharmaceutical Co., Ltd.

A Multicenter, Open-labeled, Dose-defining Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Drug Information Center
  • Phone Number: +81-3-6361-7314

Study Locations

  • Japan
      • Kanto Region, Japan
        • Recruiting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tolvaptan
Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.
Drug: Tolvaptan
Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of subject whom the body weight is decreased from baseline
Time Frame: -day1, day4
Ratio of subject whom the body weight is decreased by 1.7% or more from the baseline.
-day1, day4

Secondary Outcome Measures

Outcome Measure
Time Frame
Change the amount of daily urine volume from baseline
Time Frame: -day1 to day9
-day1 to day9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 18, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156-102-00123
  • JapicCTI-173674 (Other Identifier: Japic)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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