NCT01598441 is a Phase 3 clinical trial of iloprost nebuliser solution in Pulmonary Hypertension, sponsored by Shanghai Jiao Tong University School of Medicine.

Who is sponsoring NCT01598441?

NCT01598441 is sponsored by Shanghai Jiao Tong University School of Medicine.

What drugs are being tested in NCT01598441?

Interventions in NCT01598441: iloprost nebuliser solution, distilled water.

What condition does NCT01598441 study?

NCT01598441 studies Pulmonary Hypertension.

Is NCT01598441 still recruiting?

NCT01598441 is currently completed. Last updated 20 November 2016.

Last reviewed 2016-11-20 · How we verify

NCT01598441

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multi-centre, Randomized Study of Iloprost Inhaled in Preventing and Treating Reactive Pulmonary Hypertension (RPH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Diseases (CHD)

Completed Phase 3 Last updated 20 November 2016

What this trial tests

Phase 3 trial testing iloprost nebuliser solution in Pulmonary Hypertension in 8 participants. Completed in 1 November 2016.

Timeline

1 June 2012

Primary endpoint
1 November 2016

1 November 2016

Quick facts

Lead sponsor	Shanghai Jiao Tong University School of Medicine
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	8
Start date	1 June 2012
Primary completion	1 November 2016
Estimated completion	1 November 2016
Sites	3 locations across China

Drugs / interventions tested

iloprost nebuliser solution — full drug profile →
distilled water — full drug profile →

Conditions studied

Pulmonary Hypertension — all drugs for Pulmonary Hypertension →

Sponsor

Shanghai Jiao Tong University School of Medicine

Who can join

Adults 7 Days to 18, any sex, with Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The total incidence of RPH, PHC or death
Time frame: within 48 hours after surgery
The primary effective endpoints are reached when any individual components of the primary composite endpoint occur: * RPH lasting for more than 30 mintues; or * PHC at any time; or * death

Sponsor's own description

This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The molecular mechanisms of cardiac development and related diseases.
Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8
Prostacyclin for pulmonary arterial hypertension.
Barnes H, Yeoh HL, Fothergill T, Burns A, et al · · 2019 · cited 42× · PMID 31042010 · DOI 10.1002/14651858.cd012785.pub2

Verify or expand the search:

Other recruiting trials for Pulmonary Hypertension

Currently open trials in the same condition.

NCT07179380 — Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension · Phase 3 · recruiting
NCT07073820 — A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have P · Phase 2 · recruiting
NCT06351345 — 129 Xenon Imaging in Patients Treated With Sotatercept · Phase 2 · recruiting
NCT07187206 — Safety and Efficacy of FETO in CDH Phase III · Phase 3 · recruiting
NCT07206173 — Londrina Activities of Daily Living Protocol in Pulmonary Hypertension · recruiting

Other Shanghai Jiao Tong University School of Medicine trials

Trials by the same sponsor.

NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM · NA · not yet recruiting
NCT07528079 — Organoid-based Sensitivity-guided Chemotherapy for Advanced / Refractory Pediatric Tumors · NA · enrolling by invitation
NCT07535710 — Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-ce · Phase 1, PHASE2 · not yet recruiting
NCT07535762 — Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T · Phase 2 · not yet recruiting
NCT07350057 — A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graf · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01598441 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine
Last refreshed: 20 November 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01598441.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing