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Efficacy and safety of iNO in Pulmonary Arterial Hypertension, v1.0

  • Research type

    Research Study

  • Full title

    A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study To Determine Efficacy, Safety And Tolerability Of Pulsed, Inhaled Nitric Oxide (iNO) versus Placebo in Symptomatic Subjects With Pulmonary Arterial Hypertension (PAH): Inovation-1 (Part 1 and Part 2)

  • IRAS ID

    202601

  • Contact name

    Gerry Coghlan

  • Contact email

    gerry.coghlan@nhs.net

  • Sponsor organisation

    Bellerophon Pulse Technologies LLC

  • Eudract number

    2015-005223-90

  • Clinicaltrials.gov Identifier

    NCT02725372

  • Duration of Study in the UK

    1 years, 10 months, 30 days

  • Research summary

    The PULSE-PAH004 clinical trial investigates the efficacy and safety of pulsed, inhaled nitric oxide (a combination product featuring an investigational medicinal product (NO) delivered through a CE marked device), in selected patients who have a confirmed diagnosis of PAH Group 1 who have either idiopathic PAH (IPAH), heritable PAH, drug and toxin-induced PAH, associated PAH (APAH) with connective tissue disease (CTD), APAH with repaired simple congenital systemic to pulmonary shunt (i.e., atrial septal defect, ventricular septal defect and/or patent ductus arteriosus; complete repair at least 1 year prior to Screening), APAH with human immunodeficiency virus (HIV), or APAH with portal hypertension. This trial includes men and women aged 18 to 80 years inclusive. Patients must show willingness to use the drug-device for at least 16 hours per day. Patients should be willing to continue on the new therapy until the last subject has completed week 18 assessments. The trial is in acute care hospitals with sites around the world. The patients will have assessments included 6 minute walk distance, spirometry, blood tests (including methaemaglobin measurement, in order to assess the blood's capacity of binding oxygen) and patient reported outcomes. This trial includes a placebo-treated comparator group.

  • REC name

    London - London Bridge Research Ethics Committee

  • REC reference

    16/LO/0908

  • Date of REC Opinion

    6 Jun 2016

  • REC opinion

    Favourable Opinion