Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study

• Status: Completed
• Trial end date: 2016-12-14
• Target enrollment: 0
• Participant gender: All

Summary

This study is to investigate the efficacy, safety, and Pharmacokinetics (PK) of Inhaled Iloprost (Ventavis) therapy in Japanese pulmonary arterial hypertension (PAH) patients in Main Treatment Phase (12 weeks) and to investigate the safety, tolerability, and efficacy of longterm Inhaled Iloprost (Ventavis) therapy in Japanese PAH patients in Extension Phase.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Iloprost

Criteria

Inclusion Criteria:

• Male or female subjects aged 18 to 75 years

• Symptomatic Pulmonary Artery Hypertension (PAH) classified (Dana Point Classification 1)

• New York Heart Association (NYHA)/World Health Organization (WHO) functional class III or IV

• PAPmean at rest > 25 mm Hg, Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure(PVR) >/= 240 dyn.sec.cm-5 (>/= 400 dyn.sec.cm-5 for patients treated with both endothelin receptor antagonist (ERA) and phosphodiesterase-5 inhibitor (PDE5i) ) as measured by Right Heart Catheter test

• Women of childbearing potential and men must agree to use adequate contraception when sexually active

Exclusion Criteria:

• Baseline 6-minute walk distance of less than 100 meters or more than 500 meters

• Subjects with critical severe PAH

• Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio < 60% and/or Total Lung Capacity (TLC) < 70% predicted (especially at interstitial lung disease, TLC < 60% predicted)

• Clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive pulmonary disease )

• More than mild patchy interstitial lung disease on High Resolution Computerized Tomography (HRCT)

• History of left-sided heart disease

• Uncontrolled systemic hypertension as evidenced by systolic blood pressure >/= 160 mm Hg or diastolic blood pressure >/= 100 mm Hg on repeated measurement

• Systemic hypotension with systolic blood pressure < 85 mm Hg