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: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Hypertension, Pulmonary
Drug: Iloprost (Ventavis inhaled, BAYQ6256)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: June 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469169

Locations
Japan
Nagoya, Aichi, Japan, 466-8560
Nagoya, Aichi, Japan, 467-8602
Kurume, Fukuoka, Japan, 830-0011
Asahikwa, Hokkaido, Japan, 078-8510
Kobe, Hyogo, Japan, 650-0017
Kawasaki, Kanagawa, Japan, 216-8511
Sendai, Miyagi, Japan, 980-8574
Tomigusuku, Okinawa, Japan, 901-0243
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, 160-8582
Shinjuku-ku, Tokyo, Japan, 162-8655
Tanabe, Wakayama, Japan, 646-8558
Ube, Yamaguchi, Japan, 755-8505
Chiba, Japan, 260-8677
Tokushima, Japan, 770-8503
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01469169     History of Changes
Other Study ID Numbers: 15503
Study First Received: November 8, 2011
Last Updated: September 18, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Iloprost
Inhalation
Pulmonary Hypertension
Pulmonary Artery Hypertension
Japanese Patients

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Iloprost
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014