Pharmcokinetics, safety and efficacy of BIA-5-1058 in PAH

• Research type

  Research Study

• Full title

  An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH)

• IRAS ID

  252602

• Contact name

  Martin K Johnson

• Contact email

  mjohnson4@nhs.net

• Sponsor organisation

  Bial - Portela & Ca, S.A

• Eudract number

  2018-002448-10

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  1 years, 7 months, 0 days

• Research summary

  This study involves testing what the body does to Zamicasts and where Zamicastat goes inside the body. This information will help give patients, suffering from Pulmonary Arterial Hypertension, the 'best dose'. Once this is found, the patients will take their best dose for 42 days.

• REC name

  West of Scotland REC 1

• REC reference

  18/WS/0218

• Date of REC Opinion

  11 Feb 2019

• REC opinion

  Further Information Favourable Opinion