Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Elpen Pharmaceutical Co. Inc.
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
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or females between 18 to 75 years of age at inclusion
PAH diagnosis confirmed by right heart catheterization performed within 3 months prior to study enrolment Subjects must weigh at least 40 kg at inclusion Subject must have a current diagnosis of being in World Health Organisation (WHO) Functional Class II or III.
Treatment PAH naïve subjects PAH documented by
mPAP ≥25mmHg,
pulmonary capillary wedge pressure (PCWP) or
left ventricular end-diastolic pressure (LVEDP) ≤15mmHg and
PVR ≥3 Wood Units. Subject must walk a distance of ≥125m and ≤500m at the screening visit
You may not be if
History of pulmonary embolism
No prior treatment with PDE-5 inhibitors
History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
Current treatment with nitrates or nitric oxide
Significant (ie, \>2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
Clareo Health | Efficacy and Safety of Upfront Combination of ΒΟsentan and ΤΑdalafil in Pulmonary Arterial Hypertension
