PATENT-1: Pulmonary Artery Hypertension sGC-Stimulator Trial

• Research type

  Research Study

• Full title

  Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1mg, 1.5mg, 2mg or 2.5mg TID) in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

• IRAS ID

  6357

• Contact name

  J Pepke-Zaba

• Sponsor organisation

  Bayer Public Limited Company

• Eudract number

  2008-003482-68

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH). >Key Inclusion criteria: - Male and female patients with symptomatic PAH(Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)- Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.) Key Exclusion criteria:- All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD, uncontrolled arterial hypertension, left heart failure.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  09/H0304/6

• Date of REC Opinion

  9 Mar 2009

• REC opinion

  Further Information Favourable Opinion