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

Bayer27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension, Pulmonary

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.)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (18)

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Kurume, Fukuoka, Japan

Outcomes

Primary Outcomes

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

Time frame: At baseline and 12 weeks

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

Time frame: Up to 52 weeks

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

Time frame: At baseline, 12 weeks, 52 weeks and over 52 weeks

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

Time frame: Up to 12 weeks

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

Time frame: Over 52 weeks

Secondary Outcomes

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

Time frame: At baseline and 12 weeks

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

Time frame: At baseline and 12 weeks

Change of systolic pulmonary artery pressure from baseline to week 12

Time frame: At baseline and 12 weeks

Change of diastolic pulmonary artery pressure from baseline to week 12

Time frame: At baseline and 12 weeks

Change in Mean right atrial pressure (RAPm)

Time frame: At baseline and 12 weeks

Data from ClinicalTrials.gov

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