Efficacy and Safety of Upfront Combination of ΒΟsentan and ΤΑdalafil in Pulmonary Arterial Hypertension

Launched by ELPEN PHARMACEUTICAL CO. INC. · May 2, 2017

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or females between 18 to 75 years of age at inclusion
• Diagnosis of PAH due to the following:
• • Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
• • Hereditary PAH
• • PAH secondary to connective tissue disease
• • 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
• Exclusion Criteria:
• • 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