Status:
COMPLETED
Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study
Lead Sponsor:
Bayer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01469169
Start Date
June 19 2012
End Date
December 14 2016
Last Update
December 7 2017
Active Locations (18)
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1
Nagoya, Aichi-ken, Japan, 466-8560
2
Nagoya, Aichi-ken, Japan, 467-8602
3
Kurume, Fukuoka, Japan, 830-0011
4
Asahikwa, Hokkaido, Japan, 078-8510