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NCT04379180
Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN
trial testing Bosentan Tablets in Persistent Pulmonary Hypertension of the Newborn in 500 participants. Status unknown.
26 February 2023
Quick facts
| Lead sponsor | Shandong University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 26 April 2020 |
| Primary completion | 26 February 2023 |
| Estimated completion | 30 May 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Bosentan Tablets — full drug profile →
- Sildenafil Tablet
- Tadalafil Tablets — full drug profile →
Conditions studied
- Persistent Pulmonary Hypertension of the Newborn — all drugs for Persistent Pulmonary Hypertension of the Newborn →
Sponsor
Shandong University
Who can join
Under 28 Days, any sex, with Persistent Pulmonary Hypertension of the Newborn. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04379180
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Persistent Pulmonary Hypertension of the Newborn
Currently open trials in the same condition.
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Other Shandong University trials
Trials by the same sponsor.
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- NCT07066059 — Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period · EARLY_PHASE1 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT04379180 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shandong University
- Last refreshed: 7 May 2020
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/NCT04379180.
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