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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost (Ventavis inhaled, BAYQ6256) | Drug | 2.5 μg or 5.0 μg BAYQ6256 per inhalation session (Inhalation session is to be conducted 6 to 9 times per day with dosing intervals of at least 2 hours.) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation) | At baseline and 12 weeks | |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 52 weeks | |
| Area under the plasma concentration vs time curve from start of inhalation to infinity after single inhalation (AUC) | At baseline, 12 weeks, 52 weeks and over 52 weeks | |
| Maximum drug concentration in plasma after start of inhalation (Cmax) | Up to 12 weeks | |
| Number of participants with adverse events as a measure of safety and tolerability | Over 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pulmonary vascular resistance index (PVRI) from baseline to week 12 | At baseline and 12 weeks | |
| Change of mean of pulmonary artery pressure from baseline to week 12 | At baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 466-8560 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27001191 | Result | Saji T, Myoishi M, Sugimura K, Tahara N, Takeda Y, Fukuda K, Olschewski H, Matsuda Y, Nikkho S, Satoh T. Efficacy and Safety of Inhaled Iloprost in Japanese Patients With Pulmonary Arterial Hypertension - Insights From the IBUKI and AIR Studies. Circ J. 2016;80(4):835-42. doi: 10.1253/circj.CJ-16-0097. Epub 2016 Mar 18. |
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| Change of systolic pulmonary artery pressure from baseline to week 12 | At baseline and 12 weeks |
| Change of diastolic pulmonary artery pressure from baseline to week 12 | At baseline and 12 weeks |
| Change in Mean right atrial pressure (RAPm) | At baseline and 12 weeks |
| Change in Pulmonary capillary wedge pressure (PCWP) | At baseline and 12 weeks |
| Change in Cardiac output (CO) | At baseline and 12 weeks |
| Change in Mean arterial pressure (MAP) | At baseline and 12 weeks |
| Change Mixed venous oxygen saturation (SVO2) | At baseline and 12 weeks |
| Change in Systemic vascular resistance (SVR) | At baseline and 12 weeks |
| Change in Systemic vascular resistance index (SVRI) | At baseline and 12 weeks |
| Change in Cardiac index | At baseline and 12 weeks |
| Change in 6-minute walking test (6MWT) | At baseline, 12 weeks and 52 weeks |
| Change in Borg CR 10 Score | At baseline, 12 weeks and 52 weeks |
| Change in New York Heart Association/ World Health Organization (NYHA/WHO) class | At baseline, 12 weeks, 52 weeks and over 52 weeks |
| Change in N-terminal pro-B-type natriuretic peptide (NT-ProBNP) | At baseline, 12 weeks and 52 weeks |
| Quality of life assessed by EQ-5D and Living with Pulmonary Hypertension (LPH) questionnaires | At baseline, 12 weeks and 52 weeks |
| Time to clinical worsening during the study | At baseline, 12 weeks, 52 weeks and over 52 weeks |
| Mortality during the study | At baseline, 12 weeks, 52 weeks and over 52 weeks |
| Need for transplantation during the study | At baseline, 12 weeks, 52 weeks and over 52 weeks |
| AUC from time start of inhalation to the last data point AUC(0-tlast) | Up to 12 weeks |
| AUC divided by dose per kg body weight (AUCnorm) | Up to 12 weeks |
| AUC divided by dose (μg) (AUC/D) | Up to 12 weeks |
| Maximum drug concentration in plasma after start of inhalation divided by dose (μg) per kg body weight (Cmax,norm) | Up to 12 weeks |
| Maximum drug concentration in plasma after start of inhalation divided by dose (μg) (Cmax/D) | Up to 12 weeks |
| Time to reach maximum drug concentration in plasma after start of inhalation (tmax ) | Up to 12 weeks |
| Half-life associated with the terminal slope (t1/2) | Up to 12 weeks |
| Nagoya |
| Aichi-ken |
| 467-8602 |
| Japan |
| Kurume | Fukuoka | 830-0011 | Japan |
| Asahikwa | Hokkaido | 078-8510 | Japan |
| Kobe | Hyōgo | 650-0017 | Japan |
| Kawasaki | Kanagawa | 216-8511 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Tomigusuku | Okinawa | 901-0243 | Japan |
| Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Chuoku | Tokyo | 104-8560 | Japan |
| Mitaka | Tokyo | 181-8611 | Japan |
| Ōta-ku | Tokyo | 143-8541 | Japan |
| Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Shinjuku-ku | Tokyo | 162-8655 | Japan |
| Tanabe | Wakayama | 646-8558 | Japan |
| Ube | Yamaguchi | 755-8505 | Japan |
| Chiba | 260-8677 | Japan |
| Tokushima | 770-8503 | Japan |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D053120 | Respiratory Aspiration |
| D065627 | Familial Primary Pulmonary Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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