Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study (IBUKI)
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ClinicalTrials.gov Identifier: NCT01469169 |
Recruitment Status
:
Completed
First Posted
: November 10, 2011
Last Update Posted
: December 7, 2017
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
Tracking Information | |||||
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First Submitted Date ICMJE | November 8, 2011 | ||||
First Posted Date ICMJE | November 10, 2011 | ||||
Last Update Posted Date | December 7, 2017 | ||||
Actual Study Start Date ICMJE | June 19, 2012 | ||||
Actual Primary Completion Date | December 26, 2014 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation) [ Time Frame: At baseline and 12 weeks ] | ||||
Change History | Complete list of historical versions of study NCT01469169 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study | ||||
Official Title ICMJE | A Multi-center, Non-randomized, Open Label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of BAY q 6256 (Iloprost) Inhalation in Patients With Pulmonary Arterial Hypertension (PAH) | ||||
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 (12 weeks) and to investigate the safety, tolerability, and efficacy of longterm Inhaled Iloprost (Ventavis) therapy in Japanese PAH patients in Extension Phase. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension, Pulmonary | ||||
Intervention ICMJE | Drug: 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.) |
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Study Arms | Experimental: Arm 1
Intervention: Drug: Iloprost (Ventavis inhaled, BAYQ6256) |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
27 | ||||
Original Estimated Enrollment ICMJE |
20 | ||||
Actual Study Completion Date | December 14, 2016 | ||||
Actual Primary Completion Date | December 26, 2014 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01469169 | ||||
Other Study ID Numbers ICMJE | 15503 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Bayer | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Bayer | ||||
Verification Date | December 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |