CHEST-1: CTEPH 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 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). CHEST-1 Study

• IRAS ID

  6561

• Contact name

  J Pepke-Zaba

• Sponsor organisation

  Bayer Public Limited Company

• Eudract number

  2007-000072-16

• 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 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).#ff0000">Key Inclusion Criteria- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.Key Exclusion Criteria- All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  09/H0304/7

• Date of REC Opinion

  9 Mar 2009

• REC opinion

  Further Information Favourable Opinion