check_circleStudy Completed
Hypertension, Pulmonary
Bayer Identifier:
15503
ClinicalTrials.gov Identifier:
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
BothAge
18 - 75 YearsTrial summary
Enrollment Goal
27Trial Dates
June 2012 - December 2016Phase
Phase 3Could I Receive a placebo
NoProducts
Ventavis (Iloprost, BAYQ6256)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 weeksenhanced_encryptionNoSafety Issue:
- Number of participants with adverse events as a measure of safety and tolerabilitydate_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 tolerabilitydate_rangeTime Frame:Over 52 weeks
Secondary Outcome
- Change of Pulmonary vascular resistance index (PVRI) from baseline to week 12date_rangeTime Frame:At baseline and 12 weeksenhanced_encryptionNoSafety Issue:
- Change of mean of pulmonary artery pressure from baseline to week 12date_rangeTime Frame:At baseline and 12 weeksenhanced_encryptionNoSafety Issue:
- Change of systolic pulmonary artery pressure from baseline to week 12date_rangeTime Frame:At baseline and 12 weeksenhanced_encryptionNoSafety Issue:
- Change of diastolic pulmonary artery pressure from baseline to week 12date_rangeTime Frame:At baseline and 12 weeksenhanced_encryptionNoSafety Issue:
- 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 indexdate_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 Scoredate_rangeTime Frame:At baseline, 12 weeks and 52 weeks
- Change in New York Heart Association/ World Health Organization (NYHA/WHO) classdate_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) questionnairesdate_rangeTime Frame:At baseline, 12 weeks and 52 weeks
- Time to clinical worsening during the studydate_rangeTime Frame:At baseline, 12 weeks, 52 weeks and over 52 weeks
- Mortality during the studydate_rangeTime Frame:At baseline, 12 weeks, 52 weeks and over 52 weeks
- Need for transplantation during the studydate_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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1