Evidence map›Paper›PMID 28213957›Full record

Trial reportBritish journal of clinical pharmacology2017

A bosentan pharmacokinetic study to investigate dosing regimens in paediatric patients with pulmonary arterial hypertension: FUTURE-3.

Rolf M F Berger, Martine Gehin, Maurice Beghetti, Dunbar Ivy, Andjela Kusic-Pajic, Peter Cornelisse, Simon Grill, Damien Bonnet, FUTURE-3 investigators

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 28 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Stability Determination of an Extemporaneously Compounded Ambrisentan Suspension by High Performance Liquid Chromatography Analysis.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021
    Article
  7. Article
  8. Orphan drug development: the increasing role of clinical pharmacology.Journal of pharmacokinetics and pharmacodynamics · 2019
    Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 4 countries.

Rolf M F BergerCentre for Congenital Heart Diseases, Department of Paediatric Cardiology, Beatrix Children's Hospital, University Medical Centre, University of Groningen, Groningen, The Netherlands.
Martine GehinActelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Maurice BeghettiChildren's Hospital, Paediatric Cardiology Unit, University of Geneva, Geneva, and Centre Universitaire Romand de Cardiologie et Chirurgie Cardiaque Pédiatriques, Geneva and Lausanne, Switzerland.
Dunbar IvyChildren's Hospital Colorado, Department of Pediatric Cardiology, Denver, CO, USA.
Andjela Kusic-PajicActelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Peter CornelisseActelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Simon GrillActelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Damien BonnetM3C-Hospital Necker Enfants Malades, Department of Paediatric Cardiology, Université Paris Descartes, Paris, France.
FUTURE-3 investigators
Actelion (Switzerland) · CHChildren's Hospital Colorado · USUniversité Paris Cité · FRUniversity Medical Center Groningen · NLUniversity of Geneva · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe aim of the present study was to investigate whether increasing the bosentan dosing frequency from 2 mg kg

methodsAn open-label, prospective, randomized, multicentre, multiple-dose, phase III study was conducted. Patients (n = 64) were randomized 1:1 to receive oral doses of bosentan of 2 mg kg

resultsThe geometric mean [95% confidence interval (CI)] for AUC

conclusionsThere appeared to be no clinically relevant difference in exposure to bosentan, or in safety, when increasing the frequency of bosentan dosing from b.i.d. to t.i.d. Therefore, the present study provides no indication that the dosing recommendation should be changed, and 2 mg kg

Indexed as

Dose-Response Relationship, DrugAdministration, OralAntihypertensive AgentsArea Under CurveBosentanChildChild, PreschoolDrug Administration ScheduleEndothelin Receptor AntagonistsFemaleHumansHypertension, PulmonaryInfantMaleProspective StudiesSulfonamidesAntihypertensive AgentsBosentanEndothelin Receptor AntagonistsSulfonamidespaediatricspharmacokineticsvascular disease

Identifiers

PMID28213957
PMCPMC5510076
OpenAlexW2588690000

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.