Ignite Creation Date:
2024-05-06 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03139084
Status:
WITHDRAWN
Last Update Posted:
2018-01-26
First Post:
2017-04-28
Brief Title:
Efficacy and Safety of Upfront Combination of ΒΟsentan and ΤΑdalafil in Pulmonary Arterial Hypertension
Sponsor:
Elpen Pharmaceutical Co Inc
Organization:
Elpen Pharmaceutical Co Inc
Study Overview
Official Title:
An Observational Non-interventional Multicenter Study to Evaluate the Efficacy and Safety of Upfront Combination of Bosentan and Tadalafil in Pulmonary Arterial Hypertension in Greek Patients
Status:
WITHDRAWN
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Updated results by guidelines and bibliography
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOTA-PAH
Brief Summary:
The development of disease-targeted drugs for the treatment of pulmonary arterial hypertension PAH has significantly improved within the last years Combining drug products with different mechanisms of action such as Endothelin-Receptor-Antagonists ERAs and Phosphodiesterase-Type-5-inhibitors PDE-5-Inhibitors has become increasingly important for the treatment of PAH Recently the results of the AMBITION study reported that an upfront combination treatment of ambrisentan and tadalafil immediately after diagnosis leads to a delayed disease progression On the other hand the sequential combination of bosentan and sildenafil did not show a similar positive clinical effect and this was attributed to a negative clinically relevant pharmacodynamic drug-drug interaction Although recent guidelines have extrapolated that initial upfront combination treatment follows a class effect in terms of efficacy and safety there is an imperative need to support this notion with other combinations of ERAs and PDE-5-Inhibitors
Detailed Description:
The primary objective of BOTA study is to compare the change in clinical and hemodynamic measures of PAH after the initiation of first line combination therapy with bosentan and tadalafil in adult patients with PAH The safety and tolerability of first line combination therapy will also be evaluated
In patients with PAH initial upfront combination treatment with bosentan and tadalafil
1 Improves
Exercise capacity as expressed by distance walked in six minute walk test and WHO functional class
Hemodynamics in terms of pulmonary vascular resistance PVR mean pulmonary artery pressure mPAP reduction and cardiac index CI elevation
Quality of life
NTproBNP serum levels
Echocardiographic prognostic parameters such as right atrial area and presence of pericardial effusion
2 Is safe as assessed by
Liver function markers such as serum SGOT and SGPT levels
Hemoglobin levels
In patients with PAH initial upfront combination treatment with bosentan and tadalafil
1 Improves
Exercise capacity as expressed by distance walked in six minute walk test and WHO functional class
Hemodynamics in terms of pulmonary vascular resistance PVR mean pulmonary artery pressure mPAP reduction and cardiac index CI elevation
Quality of life
NTproBNP serum levels
Echocardiographic prognostic parameters such as right atrial area and presence of pericardial effusion
2 Is safe as assessed by
Liver function markers such as serum SGOT and SGPT levels
Hemoglobin levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None