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

December 6, 2017 updated by: Bayer

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 260-8677
      • Tokushima, Japan, 770-8503
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
      • Nagoya, Aichi, Japan, 467-8602
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
    • Hokkaido
      • Asahikwa, Hokkaido, Japan, 078-8510
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
    • Okinawa
      • Tomigusuku, Okinawa, Japan, 901-0243
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
      • Chuoku, Tokyo, Japan, 104-8560
      • Mitaka, Tokyo, Japan, 181-8611
      • Ota-ku, Tokyo, Japan, 143-8541
      • Shinjuku-ku, Tokyo, Japan, 162-8655
      • Shinjuku-ku, Tokyo, Japan, 160-8582
    • Wakayama
      • Tanabe, Wakayama, Japan, 646-8558
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
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.)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: Up to 52 weeks
Up to 52 weeks
Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation)
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Area under the plasma concentration vs time curve from start of inhalation to infinity after single inhalation (AUC)
Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks
At baseline, 12 weeks, 52 weeks and over 52 weeks
Maximum drug concentration in plasma after start of inhalation (Cmax)
Time Frame: Up to 12 weeks
Up to 12 weeks
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: Over 52 weeks
Over 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change of Pulmonary vascular resistance index (PVRI) from baseline to week 12
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change of mean of pulmonary artery pressure from baseline to week 12
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change of systolic pulmonary artery pressure from baseline to week 12
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change of diastolic pulmonary artery pressure from baseline to week 12
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change in Mean right atrial pressure (RAPm)
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change in Pulmonary capillary wedge pressure (PCWP)
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change in Cardiac output (CO)
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change in Mean arterial pressure (MAP)
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change Mixed venous oxygen saturation (SVO2)
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change in Systemic vascular resistance (SVR)
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change in Systemic vascular resistance index (SVRI)
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change in Cardiac index
Time Frame: At baseline and 12 weeks
At baseline and 12 weeks
Change in 6-minute walking test (6MWT)
Time Frame: At baseline, 12 weeks and 52 weeks
At baseline, 12 weeks and 52 weeks
Change in Borg CR 10 Score
Time Frame: At baseline, 12 weeks and 52 weeks
At baseline, 12 weeks and 52 weeks
Change in New York Heart Association/ World Health Organization (NYHA/WHO) class
Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks
At baseline, 12 weeks, 52 weeks and over 52 weeks
Change in N-terminal pro-B-type natriuretic peptide (NT-ProBNP)
Time Frame: At baseline, 12 weeks and 52 weeks
At baseline, 12 weeks and 52 weeks
Quality of life assessed by EQ-5D and Living with Pulmonary Hypertension (LPH) questionnaires
Time Frame: At baseline, 12 weeks and 52 weeks
At baseline, 12 weeks and 52 weeks
Time to clinical worsening during the study
Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks
At baseline, 12 weeks, 52 weeks and over 52 weeks
Mortality during the study
Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks
At baseline, 12 weeks, 52 weeks and over 52 weeks
Need for transplantation during the study
Time Frame: At baseline, 12 weeks, 52 weeks and over 52 weeks
At baseline, 12 weeks, 52 weeks and over 52 weeks
AUC from time start of inhalation to the last data point AUC(0-tlast)
Time Frame: Up to 12 weeks
Up to 12 weeks
AUC divided by dose per kg body weight (AUCnorm)
Time Frame: Up to 12 weeks
Up to 12 weeks
AUC divided by dose (μg) (AUC/D)
Time Frame: Up to 12 weeks
Up to 12 weeks
Maximum drug concentration in plasma after start of inhalation divided by dose (μg) per kg body weight (Cmax,norm)
Time Frame: Up to 12 weeks
Up to 12 weeks
Maximum drug concentration in plasma after start of inhalation divided by dose (μg) (Cmax/D)
Time Frame: Up to 12 weeks
Up to 12 weeks
Time to reach maximum drug concentration in plasma after start of inhalation (tmax )
Time Frame: Up to 12 weeks
Up to 12 weeks
Half-life associated with the terminal slope (t1/2)
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15503

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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