RecruitingNot Applicable

Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)

Japan30 participantsStarted 2024-12-19

Plain-language summary

This is multicenter, single-arm, non-interventional, centrally enrolled specified drug-use survey to investigate the safety of Entresto Tablets or Entresto Granules for Pediatric in pediatric patients with chronic heart failure in actual clinical settings for up to 52 weeks after administration.

Who can participate

Age range1 Year – 17 Years

SexALL

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Inclusion criteria

✓. Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto.
✓. Patients who received Entresto for the first time under the indication of chronic heart failure
✓. Pediatric patients aged 1 to \< 18 years old at the start of treatment with Entresto

Exclusion criteria

✕. Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study)
✕. Patients for whom Entresto is contraindicated according to the package insert

What they're measuring

Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration

Timeframe: one year

Trial details

NCT IDNCT06659393

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-11-30

Contact for this trial

Novartis Pharmaceuticals

+81337978748 novartis.email@novartis.com

View on ClinicalTrials.gov More Pediatric Chronic Heart Failure trials