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Completed

NCT Number: NCT01469169

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

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.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Familial Primary Pulmonary Hypertension Hypertension Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.)

Primary outcomes

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

    Time frame: At baseline and 12 weeks

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

    Time frame: Up to 52 weeks

  3. 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

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

    Time frame: Up to 12 weeks

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

    Time frame: Over 52 weeks

Secondary outcomes

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

    Time frame: At baseline and 12 weeks

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

    Time frame: At baseline and 12 weeks

  3. Change of systolic pulmonary artery pressure from baseline to week 12

    Time frame: At baseline and 12 weeks

  4. Change of diastolic pulmonary artery pressure from baseline to week 12

    Time frame: At baseline and 12 weeks

  5. Change in Mean right atrial pressure (RAPm)

    Time frame: At baseline and 12 weeks

  6. Change in Pulmonary capillary wedge pressure (PCWP)

    Time frame: At baseline and 12 weeks

  7. Change in Cardiac output (CO)

    Time frame: At baseline and 12 weeks

  8. Change in Mean arterial pressure (MAP)

    Time frame: At baseline and 12 weeks

  9. Change Mixed venous oxygen saturation (SVO2)

    Time frame: At baseline and 12 weeks

  10. Change in Systemic vascular resistance (SVR)

    Time frame: At baseline and 12 weeks

  11. Change in Systemic vascular resistance index (SVRI)

    Time frame: At baseline and 12 weeks

  12. Change in Cardiac index

    Time frame: At baseline and 12 weeks

  13. Change in 6-minute walking test (6MWT)

    Time frame: At baseline, 12 weeks and 52 weeks

  14. Change in Borg CR 10 Score

    Time frame: At baseline, 12 weeks and 52 weeks

  15. Change in New York Heart Association/ World Health Organization (NYHA/WHO) class

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

  16. Change in N-terminal pro-B-type natriuretic peptide (NT-ProBNP)

    Time frame: At baseline, 12 weeks and 52 weeks

  17. Quality of life assessed by EQ-5D and Living with Pulmonary Hypertension (LPH) questionnaires

    Time frame: At baseline, 12 weeks and 52 weeks

  18. Time to clinical worsening during the study

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

  19. Mortality during the study

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

  20. Need for transplantation during the study

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

  21. AUC from time start of inhalation to the last data point AUC(0-tlast)

    Time frame: Up to 12 weeks

  22. AUC divided by dose per kg body weight (AUCnorm)

    Time frame: Up to 12 weeks

  23. AUC divided by dose (μg) (AUC/D)

    Time frame: Up to 12 weeks

  24. Maximum drug concentration in plasma after start of inhalation divided by dose (μg) per kg body weight (Cmax,norm)

    Time frame: Up to 12 weeks

  25. Maximum drug concentration in plasma after start of inhalation divided by dose (μg) (Cmax/D)

    Time frame: Up to 12 weeks

  26. Time to reach maximum drug concentration in plasma after start of inhalation (tmax )

    Time frame: Up to 12 weeks

  27. Half-life associated with the terminal slope (t1/2)

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Acronym: IBUKI

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Nov 10, 2011
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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