86. Pulmonary arterial hypertension Clinical trials / Disease details


Clinical trials : 1,181 Drugs : 701 - (DrugBank : 126) / Drug target genes : 105 - Drug target pathways : 192

  
1 trial found
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1EUCTR2015-005223-90-IT
(EUCTR)
15/09/201622/06/2021This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.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) - Efficacy and safety of iNO in Pulmonary Arterial Hypertension, v1.0 Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: Ossido Nitrico
Other descriptive name: inhaled NO with pulsed delivery
BELLEROPHON PULSE TECHNOLOGIES LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Portugal;Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of