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: March 17, 2014
Last verified: March 2014

November 8, 2011
March 17, 2014
June 2012
October 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01469169 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension, Pulmonary
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.)
Experimental: Arm 1
Intervention: Drug: Iloprost (Ventavis inhaled, BAYQ6256)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01469169
15503
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2014

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