Statements (57)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:Clinical_Trials
|
| gptkbp:adverse_events_monitored |
serious adverse events
|
| gptkbp:advocacy |
obtained from all participants
|
| gptkbp:analysis |
descriptive statistics
intention-to-treat |
| gptkbp:business_model |
obtained from relevant boards
|
| gptkbp:clinical_trial |
Phase III
24 weeks NCT01178073 |
| gptkbp:collection |
questionnaires
|
| gptkbp:committee |
established
|
| gptkbp:comparison_group |
placebo group
|
| gptkbp:criteria |
diagnosed with pulmonary arterial hypertension
other significant comorbidities |
| gptkbp:design |
randomized controlled trial
|
| gptkbp:eligibility |
adults with pulmonary arterial hypertension
|
| gptkbp:end_date |
gptkb:2013
|
| gptkbp:events |
scheduled visits
24 weeks |
| gptkbp:field_of_study |
cardiology
|
| gptkbp:finale_date |
change from baseline in 6-minute walk distance
time to clinical worsening |
| gptkbp:focus |
pulmonary arterial hypertension
|
| gptkbp:funding |
gptkb:pharmaceuticals
|
| https://www.w3.org/2000/01/rdf-schema#label |
PATENT study
|
| gptkbp:impact |
influenced treatment guidelines
|
| gptkbp:investigates |
Dr. J. A. G. M. van der Meer
|
| gptkbp:is_studied_in |
multicenter study
|
| gptkbp:is_tested_for |
Phase III
|
| gptkbp:location |
multiple countries
|
| gptkbp:outcome |
improved quality of life
improved exercise capacity reduced risk of clinical worsening |
| gptkbp:participants |
approximately 700
quality of life exercise capacity |
| gptkbp:patient_population |
adults with WHO functional class II or III
|
| gptkbp:prevention |
parallel assignment
|
| gptkbp:publication |
gptkb:The_Lancet
peer-reviewed article |
| gptkbp:publication_year |
gptkb:2013
|
| gptkbp:randomization_method |
computer-generated random numbers
|
| gptkbp:recruitment |
completed in 2012
|
| gptkbp:regulatory_compliance |
gptkb:FDA
gptkb:EMA |
| gptkbp:related_products |
gptkb:macitentan
|
| gptkbp:research_output |
published in 2013
|
| gptkbp:result |
gptkb:The_Lancet
|
| gptkbp:sponsor |
gptkb:Boehringer_Ingelheim
|
| gptkbp:start_date |
gptkb:2011
|
| gptkbp:study_objective |
evaluate efficacy and safety
|
| gptkbp:study_results_summary |
macitentan improved outcomes
|
| gptkbp:treatment |
gptkb:macitentan
|
| gptkbp:vision |
double blind
|
| gptkbp:year |
gptkb:2013
|
| gptkbp:bfsParent |
gptkb:Opsumit
|
| gptkbp:bfsLayer |
6
|