Overview

This trial is active, not recruiting.

Condition hypertension, pulmonary
Treatment iloprost (ventavis inhaled, bayq6256)
Phase phase 3
Sponsor Bayer
Start date June 2012
End date December 2014
Trial size 27 participants
Trial identifier NCT01469169, 15503

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.)

Primary Outcomes

Measure
Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation)
time frame: At baseline and 12 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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 /= 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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bayer.