Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study
NCT ID: NCT01469169
Last Updated: 2017-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
27 participants
INTERVENTIONAL
2012-06-19
2016-12-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Iloprost (Ventavis inhaled, BAYQ6256)
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.)
Interventions
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Iloprost (Ventavis inhaled, BAYQ6256)
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.)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Kurume, Fukuoka, Japan
Asahikwa, Hokkaido, Japan
Kobe, Hyōgo, Japan
Kawasaki, Kanagawa, Japan
Sendai, Miyagi, Japan
Tomigusuku, Okinawa, Japan
Bunkyo-ku, Tokyo, Japan
Chuoku, Tokyo, Japan
Mitaka, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Tanabe, Wakayama, Japan
Ube, Yamaguchi, Japan
Chiba, , Japan
Tokushima, , Japan
Countries
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References
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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.
Other Identifiers
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15503
Identifier Type: -
Identifier Source: org_study_id