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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 Th...

Update Il y a 4 ans
Reference: EUCTR2007-000072-16

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)

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Extract

To assess the efficacy and safety of oral BAY 63-2521 in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or recurrent or persisting pulmonary hypertension after surgical treatment. The optimized dose reached after individual dose titration (starting with 1 mg tid and if tolerated up-titrated after two weeks up to 1.5 mg or 2 mg or 2.5 mg tid) will be compared with placebo.

Inclusion criteria

  • Chronic Thromboembolic Pulmonary Hypertension

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