check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

15503

ClinicalTrials.gov Identifier:

NCT01469169

EudraCT Number:

Not Available

EU CT Number:

Not Available
Inhaled Iloprost (Ventavis): efficacy, safety, and pharmacokinetics (PK) confirmation study

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years

  • - 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

  • - 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

Trial summary

Enrollment Goal
27
Trial Dates
June 2012 - December 2016
Phase
Phase 3
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Ota-ku, 143-8541, Japan
Completed
Tanabe, 646-8558, Japan
Terminated
Asahikwa, 078-8510, Japan
Completed
Ube, 755-8505, Japan
Completed
Tokushima, 770-8503, Japan
Completed
Chuoku, 104-8560, Japan
Completed
Bunkyo-ku, 113-8655, Japan
Completed
Chiba, 260-8677, Japan
Completed
Sendai, 980-8574, Japan
Completed
Tomigusuku, 901-0243, Japan
Completed
Nagoya, 467-8602, Japan
Completed
Shinjuku-ku, 162-8655, Japan
Completed
Kawasaki, 216-8511, Japan
Completed
Shinjuku-ku, 160-8582, Japan
Completed
Mitaka, 181-8611, Japan
Completed
Nagoya, 466-8560, Japan
Completed
Kurume, 830-0011, Japan
Completed
Kobe, 650-0017, Japan

Primary Outcome

  • Change in Pulmonary vascular resistance (PVR) from screening (baseline) to week 12 (after inhalation)
    date_rangeTime Frame:
    At baseline and 12 weeks
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    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 52 weeks
  • Area under the plasma concentration vs time curve from start of inhalation to infinity after single inhalation (AUC)
    date_rangeTime Frame:
    At baseline, 12 weeks, 52 weeks and over 52 weeks
  • Maximum drug concentration in plasma after start of inhalation (Cmax)
    date_rangeTime Frame:
    Up to 12 weeks
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Over 52 weeks

Secondary Outcome

  • Change of Pulmonary vascular resistance index (PVRI) from baseline to week 12
    date_rangeTime Frame:
    At baseline and 12 weeks
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    Safety Issue:
    No
  • Change of mean of pulmonary artery pressure from baseline to week 12
    date_rangeTime Frame:
    At baseline and 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change of systolic pulmonary artery pressure from baseline to week 12
    date_rangeTime Frame:
    At baseline and 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change of diastolic pulmonary artery pressure from baseline to week 12
    date_rangeTime Frame:
    At baseline and 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change in Mean right atrial pressure (RAPm)
    date_rangeTime Frame:
    At baseline and 12 weeks
  • Change in Pulmonary capillary wedge pressure (PCWP)
    date_rangeTime Frame:
    At baseline and 12 weeks
  • Change in Cardiac output (CO)
    date_rangeTime Frame:
    At baseline and 12 weeks
  • Change in Mean arterial pressure (MAP)
    date_rangeTime Frame:
    At baseline and 12 weeks
  • Change Mixed venous oxygen saturation (SVO2)
    date_rangeTime Frame:
    At baseline and 12 weeks
  • Change in Systemic vascular resistance (SVR)
    date_rangeTime Frame:
    At baseline and 12 weeks
  • Change in Systemic vascular resistance index (SVRI)
    date_rangeTime Frame:
    At baseline and 12 weeks
  • Change in Cardiac index
    date_rangeTime Frame:
    At baseline and 12 weeks
  • Change in 6-minute walking test (6MWT)
    date_rangeTime Frame:
    At baseline, 12 weeks and 52 weeks
  • Change in Borg CR 10 Score
    date_rangeTime Frame:
    At baseline, 12 weeks and 52 weeks
  • Change in New York Heart Association/ World Health Organization (NYHA/WHO) class
    date_rangeTime Frame:
    At baseline, 12 weeks, 52 weeks and over 52 weeks
  • Change in N-terminal pro-B-type natriuretic peptide (NT-ProBNP)
    date_rangeTime Frame:
    At baseline, 12 weeks and 52 weeks
  • Quality of life assessed by EQ-5D and Living with Pulmonary Hypertension (LPH) questionnaires
    date_rangeTime Frame:
    At baseline, 12 weeks and 52 weeks
  • Time to clinical worsening during the study
    date_rangeTime Frame:
    At baseline, 12 weeks, 52 weeks and over 52 weeks
  • Mortality during the study
    date_rangeTime Frame:
    At baseline, 12 weeks, 52 weeks and over 52 weeks
  • Need for transplantation during the study
    date_rangeTime Frame:
    At baseline, 12 weeks, 52 weeks and over 52 weeks
  • AUC from time start of inhalation to the last data point AUC(0-tlast)
    date_rangeTime Frame:
    Up to 12 weeks
  • AUC divided by dose per kg body weight (AUCnorm)
    date_rangeTime Frame:
    Up to 12 weeks
  • AUC divided by dose (μg) (AUC/D)
    date_rangeTime Frame:
    Up to 12 weeks
  • Maximum drug concentration in plasma after start of inhalation divided by dose (μg) per kg body weight (Cmax,norm)
    date_rangeTime Frame:
    Up to 12 weeks
  • Maximum drug concentration in plasma after start of inhalation divided by dose (μg) (Cmax/D)
    date_rangeTime Frame:
    Up to 12 weeks
  • Time to reach maximum drug concentration in plasma after start of inhalation (tmax )
    date_rangeTime Frame:
    Up to 12 weeks
  • Half-life associated with the terminal slope (t1/2)
    date_rangeTime Frame:
    Up to 12 weeks

Trial design

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 Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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