Safety and efficacy of BIA 5-1058 in PAH

• Research type

  Research Study

• Full title

  An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease.

• IRAS ID

  256589

• Contact name

  Martin K Johnson

• Contact email

  martin.johnson@ggc.scot.nhs.uk

• Sponsor organisation

  Bial - Portela & Ca, S.A

• Eudract number

  2018-002796-18

• Clinicaltrials.gov Identifier

  NCT04316143

• Duration of Study in the UK

  1 years, 10 months, 0 days

• Research summary

  Reserach Summary

  This is an extension study from the BIA-51058-201 study, where patients take Zamicastat long-term (12 weeks) to test if this is safe and if it works in patients suffering from Pulmonary Arterial Hypertension.

  Summary of Results

  The results of the study show that zamicastat is absorbed into the body between 2 and 4 hours after taking it. The safety results show zamicastat is safe to use too.

• REC name

  West of Scotland REC 1

• REC reference

  19/WS/0032

• Date of REC Opinion

  12 Mar 2019

• REC opinion

  Favourable Opinion