At a glance
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Study AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study -
In Brief
A Phase 3 clinical trial evaluating GSK1325760A for Pulmonary Arterial Hypertension and Hypertension, Pulmonary. Completed, enrolled 21 participants across 11 sites.
Detailed Summary
The primary objective of this study is to evaluate the safety of long-term administration of GSK1325760A in patients with PAH. The secondary objectives of this study are to evaluate long-term administration of GSK1325760A on: * Improvement in exercise capacity (six-minutes walk distance: 6MWD), change in WHO Functional Classification and time to clinical worsening of PAH * Change in the Borg Dyspnea Index (assessed immediately following the six-minute walk test \[6MWT\]) * Change in plasma brain natriuretic peptide (BNP) levels * Cardiopulmonary hemodynamics parameters (as measured by echocardiography)
Study Details
Timeline
Interventions
2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW.