Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Primary Purpose
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Tolvaptan
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
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
Sites / Locations
- Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tolvaptan
Arm Description
Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.
Outcomes
Primary Outcome Measures
Ratio of subject whom the body weight is decreased from baseline
Ratio of subject whom the body weight is decreased by 1.7% or more from the baseline.
Secondary Outcome Measures
Change the amount of daily urine volume from baseline
Full Information
NCT ID
NCT03255226
First Posted
August 18, 2017
Last Updated
January 11, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03255226
Brief Title
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tolvaptan
Arm Type
Experimental
Arm Description
Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Intervention Description
Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.
Primary Outcome Measure Information:
Title
Ratio of subject whom the body weight is decreased from baseline
Description
Ratio of subject whom the body weight is decreased by 1.7% or more from the baseline.
Time Frame
-day1, day4
Secondary Outcome Measure Information:
Title
Change the amount of daily urine volume from baseline
Time Frame
-day1 to day9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Drug Information Center
Phone
+81-3-6361-7314
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Ono, Mr
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Kanto Region
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
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