Trial Condition(s):

Hypertension, Pulmonary

Inhaled Iloprost (Ventavis): efficacy, safety, and pharmacokinetics (PK) confirmation study (IBUKI)

Bayer Identifier:

15503

ClinicalTrials.gov Identifier:

NCT01469169

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
27
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Ota-ku, Japan, 143-8541

Status
Completed
 
Locations

Investigative Site

Tanabe, Japan, 646-8558

Status
Completed
 
Locations

Investigative Site

Asahikwa, Japan, 078-8510

Status
Terminated
 
Locations

Investigative Site

Ube, Japan, 755-8505

Status
Completed
 
Locations

Investigative Site

Tokushima, Japan, 770-8503

Status
Completed
 
Locations

Investigative Site

Chuoku, Japan, 104-8560

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Investigative Site

Chiba, Japan, 260-8677

Status
Completed
 
Locations

Investigative Site

Sendai, Japan, 980-8574

Status
Completed
 
Locations

Investigative Site

Tomigusuku, Japan, 901-0243

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 467-8602

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8655

Status
Completed
 
Locations

Investigative Site

Kawasaki, Japan, 216-8511

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 160-8582

Status
Completed
 
Locations

Investigative Site

Mitaka, Japan, 181-8611

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 466-8560

Status
Completed
 
Locations

Investigative Site

Kurume, Japan, 830-0011

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0017

Status
Completed
 

Trial Design