Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study (IBUKI)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bayer

ClinicalTrials.gov Identifier:

NCT01469169

First received: November 8, 2011

Last updated: March 30, 2017

Last verified: March 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2011

Last Updated Date

March 30, 2017

Actual Start Date ^ICMJE

June 19, 2012

Primary Completion Date

December 26, 2014 (Final data collection date for primary outcome measure)

Current 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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01469169 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change of Pulmonary vascular resistance index (PVRI) from baseline to week 12 [ Time Frame: At baseline and 12 weeks ]
Change of mean of pulmonary artery pressure from baseline to week 12 [ Time Frame: At baseline and 12 weeks ]
Change of systolic pulmonary artery pressure from baseline to week 12 [ Time Frame: At baseline and 12 weeks ]
Change of diastolic pulmonary artery pressure from baseline to week 12 [ Time Frame: At baseline and 12 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

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

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.)

Study Arms

Experimental: Arm 1

Intervention: Drug: Iloprost (Ventavis inhaled, BAYQ6256)

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 14, 2016

Primary Completion Date

December 26, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Bayer

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

PRS Account

Bayer

Verification Date

March 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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