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

Bayer

Status and phase: Completed; Phase 3

Conditions: Hypertension, Pulmonary

Treatments: Drug: Iloprost (Ventavis inhaled, BAYQ6256)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01469169

15503

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 </= 15 mm Hg and Pulmonary Vascular resistance (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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Iloprost (Ventavis inhaled, BAYQ6256)