ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03255226
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload Drug: Tolvaptan Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Tolvaptan
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change the amount of daily urine volume from baseline [ Time Frame: -day1 to day9 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255226


Contacts
Contact: Drug Information Center +81-3-6361-7314

Locations
Japan
Recruiting
Kanto Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Hiroaki Ono, Mr Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03255226     History of Changes
Other Study ID Numbers: 156-102-00123
JapicCTI-173674 ( Other Identifier: Japic )
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs