NCT01469169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_3

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

June 19, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2016

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

November 8, 2011

Last Update Submit

December 6, 2017

Conditions

Hypertension, Pulmonary

Keywords

IloprostInhalationPulmonary HypertensionPulmonary Artery HypertensionJapanese Patients

Outcome Measures

Primary Outcomes (5)

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

    At baseline and 12 weeks

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

    Up to 52 weeks

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

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

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

    Up to 12 weeks

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

    Over 52 weeks

Secondary Outcomes (27)

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

    At baseline and 12 weeks

  • Change of mean of pulmonary artery pressure from baseline to week 12

    At baseline and 12 weeks

  • Change of systolic pulmonary artery pressure from baseline to week 12

    At baseline and 12 weeks

  • Change of diastolic pulmonary artery pressure from baseline to week 12

    At baseline and 12 weeks

  • Change in Mean right atrial pressure (RAPm)

    At baseline and 12 weeks

  • +22 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Iloprost (Ventavis inhaled, BAYQ6256)

Interventions

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.)

Arm 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Nagoya, Aichi-ken, 466-8560, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 467-8602, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-0011, Japan

Location

Unknown Facility

Asahikwa, Hokkaido, 078-8510, Japan

Location

Unknown Facility

Kobe, Hyōgo, 650-0017, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 216-8511, Japan

Location

Unknown Facility

Sendai, Miyagi, 980-8574, Japan

Location

Unknown Facility

Tomigusuku, Okinawa, 901-0243, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Unknown Facility

Chuoku, Tokyo, 104-8560, Japan

Location

Unknown Facility

Mitaka, Tokyo, 181-8611, Japan

Location

Unknown Facility

Ōta-ku, Tokyo, 143-8541, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, 162-8655, Japan

Location

Unknown Facility

Tanabe, Wakayama, 646-8558, Japan

Location

Unknown Facility

Ube, Yamaguchi, 755-8505, Japan

Location

Unknown Facility

Chiba, 260-8677, Japan

Location

Unknown Facility

Tokushima, 770-8503, Japan

Location

Related Publications (1)

  • 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.

    PMID: 27001191RESULT

MeSH Terms

Conditions

Hypertension, PulmonaryRespiratory AspirationFamilial Primary Pulmonary Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 10, 2011

Study Start

June 19, 2012

Primary Completion

December 26, 2014

Study Completion

December 14, 2016

Last Updated

December 7, 2017

Record last verified: 2017-12

Locations

JP(18)