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

Hypertension, Pulmonary Clinical Trial

— IBUKI  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469169
• Other study ID #: 15503
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2011
• Last updated: December 6, 2017
• Start date: June 19, 2012
• Est. completion date: December 14, 2016

Study information

• Verified date: December 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Japanese PAH patients in Extension Phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 14, 2016
• Est. primary completion date: December 26, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

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.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

References & 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation)		At baseline and 12 weeks
Primary	Number of participants with adverse events as a measure of safety and tolerability		Up to 52 weeks
Primary	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
Primary	Maximum drug concentration in plasma after start of inhalation (Cmax)		Up to 12 weeks
Primary	Number of participants with adverse events as a measure of safety and tolerability		Over 52 weeks
Secondary	Change of Pulmonary vascular resistance index (PVRI) from baseline to week 12		At baseline and 12 weeks
Secondary	Change of mean of pulmonary artery pressure from baseline to week 12		At baseline and 12 weeks
Secondary	Change of systolic pulmonary artery pressure from baseline to week 12		At baseline and 12 weeks
Secondary	Change of diastolic pulmonary artery pressure from baseline to week 12		At baseline and 12 weeks
Secondary	Change in Mean right atrial pressure (RAPm)		At baseline and 12 weeks
Secondary	Change in Pulmonary capillary wedge pressure (PCWP)		At baseline and 12 weeks
Secondary	Change in Cardiac output (CO)		At baseline and 12 weeks
Secondary	Change in Mean arterial pressure (MAP)		At baseline and 12 weeks
Secondary	Change Mixed venous oxygen saturation (SVO2)		At baseline and 12 weeks
Secondary	Change in Systemic vascular resistance (SVR)		At baseline and 12 weeks
Secondary	Change in Systemic vascular resistance index (SVRI)		At baseline and 12 weeks
Secondary	Change in Cardiac index		At baseline and 12 weeks
Secondary	Change in 6-minute walking test (6MWT)		At baseline, 12 weeks and 52 weeks
Secondary	Change in Borg CR 10 Score		At baseline, 12 weeks and 52 weeks
Secondary	Change in New York Heart Association/ World Health Organization (NYHA/WHO) class		At baseline, 12 weeks, 52 weeks and over 52 weeks
Secondary	Change in N-terminal pro-B-type natriuretic peptide (NT-ProBNP)		At baseline, 12 weeks and 52 weeks
Secondary	Quality of life assessed by EQ-5D and Living with Pulmonary Hypertension (LPH) questionnaires		At baseline, 12 weeks and 52 weeks
Secondary	Time to clinical worsening during the study		At baseline, 12 weeks, 52 weeks and over 52 weeks
Secondary	Mortality during the study		At baseline, 12 weeks, 52 weeks and over 52 weeks
Secondary	Need for transplantation during the study		At baseline, 12 weeks, 52 weeks and over 52 weeks
Secondary	AUC from time start of inhalation to the last data point AUC(0-tlast)		Up to 12 weeks
Secondary	AUC divided by dose per kg body weight (AUCnorm)		Up to 12 weeks
Secondary	AUC divided by dose (µg) (AUC/D)		Up to 12 weeks
Secondary	Maximum drug concentration in plasma after start of inhalation divided by dose (µg) per kg body weight (Cmax,norm)		Up to 12 weeks
Secondary	Maximum drug concentration in plasma after start of inhalation divided by dose (µg) (Cmax/D)		Up to 12 weeks
Secondary	Time to reach maximum drug concentration in plasma after start of inhalation (tmax )		Up to 12 weeks
Secondary	Half-life associated with the terminal slope (t1/2)		Up to 12 weeks

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