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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Bayer

ClinicalTrials.gov Identifier:

NCT01469169

First received: November 8, 2011

Last updated: December 15, 2014

Last verified: December 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2011

Last Updated Date

December 15, 2014

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

December 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
Change of mean of pulmonary artery pressure from baseline to week 12 [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
Change of systolic pulmonary artery pressure from baseline to week 12 [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]
Change of diastolic pulmonary artery pressure from baseline to week 12 [ Time Frame: At baseline and 12 weeks ] [ Designated as safety issue: No ]

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

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

Experimental: Arm 1

Intervention: Drug: Iloprost (Ventavis inhaled, BAYQ6256)

Publications *

Not Provided

* 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

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

April 2016

Estimated Primary Completion Date

December 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

Gender

Both

Ages

18 Years to 75 Years

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

Responsible Party

Bayer

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

December 2014

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

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