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NCT04090697 · ClinicalTrials.gov registry record · Phase 1

Use of Oxandrolone to Promote Growth in Infants With HLHS

A Phase 1 study, sponsored by Carelon Research.

Terminated
Registry status
Phase 1
Development phase
34
Enrollment target

NCT04090697 is a Phase 1 study that was terminated before completion, run by Carelon Research. The registered enrollment target is 34 participants.

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The verdict

NCT04090697, a Phase 1 study, was terminated before completion, sponsored by Carelon Research.

TERMINATED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

The primary aim of this study is to determine if clinically relevant doses of buccally administered oxandrolone are safe and tolerable in neonates with hypoplastic left heart syndrome (HLHS) or other single right ventricular anomalies who have undergone a Norwood procedure. The secondary aim is to evaluate the efficacy of buccally administered oxandrolone in improving objective indices of growth and nutrition in neonates who have undergone a Norwood procedure.

Interventions

  • DRUG Oxandrolone

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2019-12-20
Est. Completion 2023-09-19
Phase Phase 1

Sponsor

Carelon Research

50 total trials

What the Registry Record Tells You About NCT04090697

The ClinicalTrials.gov registry entry for NCT04090697 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 50 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Oxandrolone is the first listed.

NCT04090697 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04090697 about?

NCT04090697 is a clinical study titled "Use of Oxandrolone to Promote Growth in Infants With HLHS". The primary aim of this study is to determine if clinically relevant doses of buccally administered oxandrolone are safe and tolerable in neonates with hypoplastic left heart syndrome (HLHS) or other single right ventricular anomalies who have undergone a Norwood procedure. The secondary aim is to e...

What is the current status of trial NCT04090697?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2019-12-20. Estimated completion is 2023-09-19.

What interventions are being tested in trial NCT04090697?

The interventions under investigation include: Oxandrolone (DRUG).

Who is sponsoring clinical trial NCT04090697?

This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.