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Hypertension, PulmonaryPhase 3IBUKINCT01469169

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

A Phase 3 study testing Iloprost (Ventavis inhaled, BAYQ6256) in people with Hypertension, Pulmonary, run by Bayer at 18 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension, Pulmonary
What is being tested?
Iloprost (Ventavis inhaled, BAYQ6256)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
18 sitesJapan
Study dates
19 Jun 2012to 14 Dec 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Japan18 sites

  • Study site

    Asahikwa, Hokkaido, 078-8510

  • Study site

    Bunkyo-ku, Tokyo, 113-8655

  • Study site

    Chiba, 260-8677

  • Study site

    Chuoku, Tokyo, 104-8560

  • Study site

    Kawasaki, Kanagawa, 216-8511

  • Study site

    Kobe, Hyōgo, 650-0017

  • Study site

    Kurume, Fukuoka, 830-0011

  • Study site

    Mitaka, Tokyo, 181-8611

  • Study site

    Nagoya, Aichi-ken, 466-8560

  • Study site

    Nagoya, Aichi-ken, 467-8602

  • Study site

    Ōta-ku, Tokyo, 143-8541

  • Study site

    Sendai, Miyagi, 980-8574

  • Study site

    Shinjuku-ku, Tokyo, 160-8582

  • Study site

    Shinjuku-ku, Tokyo, 162-8655

  • Study site

    Tanabe, Wakayama, 646-8558

  • Study site

    Tokushima, 770-8503

  • Study site

    Tomigusuku, Okinawa, 901-0243

  • Study site

    Ube, Yamaguchi, 755-8505

Other trials in Japan

About this study

Official title: 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.

Being tested
Iloprost (Ventavis inhaled, BAYQ6256)
Keywords
Iloprost, Inhalation, Pulmonary Hypertension, Pulmonary Artery Hypertension, Japanese Patients
Medical subject headings
Hypertension, Pulmonary, Respiratory Aspiration, Familial Primary Pulmonary Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iloprost (Ventavis inhaled, BAYQ6256)Drug

    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 groups in NCT01469169
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Iloprost (Ventavis inhaled, BAYQ6256)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation)

    Measured: At baseline and 12 weeks

  2. Number of participants with adverse events as a measure of safety and tolerability

    Measured: Up to 52 weeks

  3. Area under the plasma concentration vs time curve from start of inhalation to infinity after single inhalation (AUC)

    Measured: At baseline, 12 weeks, 52 weeks and over 52 weeks

  4. Maximum drug concentration in plasma after start of inhalation (Cmax)

    Measured: Up to 12 weeks

  5. Number of participants with adverse events as a measure of safety and tolerability

    Measured: Over 52 weeks

Secondary outcomes (27)

  1. Change of Pulmonary vascular resistance index (PVRI) from baseline to week 12

    Measured: At baseline and 12 weeks

  2. Change of mean of pulmonary artery pressure from baseline to week 12

    Measured: At baseline and 12 weeks

  3. Change of systolic pulmonary artery pressure from baseline to week 12

    Measured: At baseline and 12 weeks

  4. Change of diastolic pulmonary artery pressure from baseline to week 12

    Measured: At baseline and 12 weeks

  5. Change in Mean right atrial pressure (RAPm)

    Measured: At baseline and 12 weeks

  6. Change in Pulmonary capillary wedge pressure (PCWP)

    Measured: At baseline and 12 weeks

  7. Change in Cardiac output (CO)

    Measured: At baseline and 12 weeks

  8. Change in Mean arterial pressure (MAP)

    Measured: At baseline and 12 weeks

  9. Change Mixed venous oxygen saturation (SVO2)

    Measured: At baseline and 12 weeks

  10. Change in Systemic vascular resistance (SVR)

    Measured: At baseline and 12 weeks

  11. Change in Systemic vascular resistance index (SVRI)

    Measured: At baseline and 12 weeks

  12. Change in Cardiac index

    Measured: At baseline and 12 weeks

  13. Change in 6-minute walking test (6MWT)

    Measured: At baseline, 12 weeks and 52 weeks

  14. Change in Borg CR 10 Score

    Measured: At baseline, 12 weeks and 52 weeks

  15. Change in New York Heart Association/ World Health Organization (NYHA/WHO) class

    Measured: At baseline, 12 weeks, 52 weeks and over 52 weeks

  16. Change in N-terminal pro-B-type natriuretic peptide (NT-ProBNP)

    Measured: At baseline, 12 weeks and 52 weeks

  17. Quality of life assessed by EQ-5D and Living with Pulmonary Hypertension (LPH) questionnaires

    Measured: At baseline, 12 weeks and 52 weeks

  18. Time to clinical worsening during the study

    Measured: At baseline, 12 weeks, 52 weeks and over 52 weeks

  19. Mortality during the study

    Measured: At baseline, 12 weeks, 52 weeks and over 52 weeks

  20. Need for transplantation during the study

    Measured: At baseline, 12 weeks, 52 weeks and over 52 weeks

  21. AUC from time start of inhalation to the last data point AUC(0-tlast)

    Measured: Up to 12 weeks

  22. AUC divided by dose per kg body weight (AUCnorm)

    Measured: Up to 12 weeks

  23. AUC divided by dose (μg) (AUC/D)

    Measured: Up to 12 weeks

  24. Maximum drug concentration in plasma after start of inhalation divided by dose (μg) per kg body weight (Cmax,norm)

    Measured: Up to 12 weeks

  25. Maximum drug concentration in plasma after start of inhalation divided by dose (μg) (Cmax/D)

    Measured: Up to 12 weeks

  26. Time to reach maximum drug concentration in plasma after start of inhalation (tmax )

    Measured: Up to 12 weeks

  27. Half-life associated with the terminal slope (t1/2)

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2011 (estimated)
  2. Study start19 Jun 2012
  3. Primary completion26 Dec 2014
  4. Study completion14 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01469169
Sponsor's protocol ID
15503
Acronym
IBUKI
Status last verified
Dec 2017
First submitted
8 Nov 2011
Last updated
7 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 27001191

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Iloprost (Ventavis inhaled, BAYQ6256) in people with Hypertension, Pulmonary, run by Bayer at 18 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation) (time frame: At baseline and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01469169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.

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