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Ammendment of protocol: Intravenous iron treatment in iron deficient patients with idiopathic pulmonary arterial hypertension. Title amendment: Skeletal muscle strength in healthy persons and patients with pulmonary hypertension

To evaluate the effects of intravenous iron suppletion in iron deficient PAH patients.Amendment: to compare exercise capacity and isolated muscle strength in IPAH patients and healthy controls

Patterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment - The REDUQ II study

The REDUQ II study will be conducted to help us to complete data on the secondary endpoints of the REDUQ study (P09-22) and arrange and examine relationships occurring between and among intervention elements of the REDUQ study, behavioural and…

ChanGes In Right ventricular volumes And Function Following diurEtic Treatment In Pulmonary arterial hypertension patients with decompensated right heart failure (GIRAFFE)

The primary objective of the study is to evaluate the effect of diuretics on right ventricular function and volume properties in patients with symptomatic right heart failure and PH.

A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging

The primary objective of the study is to evaluate the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic PAH.Secondary objectivesTo evaluate the safety and tolerability of macitentan in patients with…

The power and the flow: raising the bars in the treatment of pulmonary arterial hypertension

The primary goal of the study is to assess whether a goal oriented strategy to preserve/improve right ventricular function by application of upfront combination therapy will improve clinical outcome. Study questions:1. Will a goal oriented strategy…

Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT-064992 in patients with symptomatic pulmonary arterial hypertension

To assess the long-term safety and tolerability of macitentan in patients with symptomatic pulmonary arterial hypertension (PAH).

Intravenous Administration of In Vitro Expanded Mesenchymal Stem Cells in Patients with Pulmonary Arterial Hypertension due to Systemic Sclerosis;
A Safety and Feasibility Study

The main objective is assessment of safety and feasibility of intravenous administration of autologous, in vitro expanded, mesenchymal stem cells in patients with pulmonary arterial hypertension due to systemic sclerosis. The secondary objective is…

A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension

To evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension (PAH).

A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension

- To evaluate the change in cardiac hemodynamics from baseline to 3-month following switch from Flolan to EFI in patients with PAH.- To evaluate the safety and tolerability of switching from Flolan to EFI in patients with PAH.- To evaluate the…

Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the long-term safety and tolerability of BAY 63 2521 in the treatment…

A Single-arm Open Label Study Evaluating the Impact on Lifestyle of a New Thermo-stable Formulation of Flolan in Subjects with Pulmonary Arterial Hypertension (PAH) (FLR115332)

Primary:* To describe the effect of the new thermo stable formulation of FLOLAN on quality of life in patients switching from the currently marketed FLOLAN to the new thermo stable formulation.* To determine the dose titration requirementSecondary…

Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability 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).

BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the longterm safety and tolerability of oral BAY 63-2521 in patients…

A single-center, open-label, randomized, two-period, two-treatment, crossover study in healthy male subjects to demonstrate bioequivalence of 1600 mcg selexipag administered as eight tablets of 200 mcg (reference drug) or as single tablet of 1600 mcg (test drug)

- To demonstrate bioequivalence of test drug and reference drug - Safety and tolerability- Investigate phamacokinetic properties of selexipag and its metabolite

AMB116457: An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Primary: to assess the longterm safety and tolerability of ambrisentan 5mg in subjects with inoperable CTEPH. Secondary: to collect supportive efficacy data.

An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial

Objectives of the study are to assess safety, tolerability and clinical effects of riociguat and provide access to inoperable patients for a condition (CTEPH) with unmet medical need.

An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension

To provide, or continue to provide, UT-15C SR for eligible subjects who participated in protocols TDE-PH-301 or TDE-PH-302 or TDE-PH-308 or additional UC-15C SR clinical protocols.To assess the long-term safety of UT-15C SR in these subjects through…

An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH)

To assess safety and tolerability of EFI patients with PAH.

An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension.

Primary: To evaluate the long-term safety and tolerability of QTI571.Secondary: * Continue to evaluate the long-term efficacy of QTI571 as measured by the change in6MWD from baseline.* Continue to assess time to clinical worsening (TTCW) endpoints…

An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired (AMB114588)

Primary: Longterm safety and tolerability of 2 dosages of ambrisentan. Secundary: Supportive efficacy data.

A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years (AMB112529)

Primary: Safety and tolerability of 2 dosages of ambrisentan. Secundary: Efficacy and PK.