Trial Condition(s):

Pulmonary arterial hypertension

Comparative PK PD Study in PAH patients (Fox vs. I-Neb)

Bayer Identifier:

16483

ClinicalTrials.gov Identifier:

NCT02032836

EudraCT Number:

2013-002783-12

Study Completed

Trial Purpose

Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb

Inclusion Criteria
- Male or female aged ≥ 18 years
- Current diagnosis of pulmonary hypertension (updated Dana Point Classification 1).
- Current inhalative therapy with 5 µg iloprost using the 
I-Neb nebulizer
- WHO functional class III at the time of the patient's commencement of inhalative therapy with iloprost
- Hemodynamic diagnosis of Pulmonary arterial hypertension(PAH) showing mean pulmonary arterial pressure (mPAP) > 25 mmHg, pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) < 15 mmHg and pulmonary vascular resistance (PVR) > 320 dyn•s•cm–5
- If non-specific types of chronic treatment for PAH are being administered: Stable dosage of these for at least the 4 weeks up to screening
- If PAH-specific drug treatments (such as endothelin receptor antagonist (ERA) or phosphodiesterase-5 (PDE5) inhibitors) are being administered: Stable dosage of these for at least the 3 months up to screening.
Exclusion Criteria
-PAH related to any other etiology, especially to pulmonary veno-occlusive disease (PVOD)
- Clinically relevant obstructive lung disease
- Evidence of thromboembolic disease (probable pulmonary embolism) within 3 years before screening
- Cerebrovascular events within 3 months before screening
- Atrial septostomy within the 6 months before screening
- Severe arrhythmia, or severe coronary heart disease or unstable angina, or myocardial infarction within 6 months before screening, or congenital or acquired valvular defects with clinically relevant myocardial function disorders unrelated to PAH
- Systolic blood pressure < 85 mm Hg, or uncontrolled systemic hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg) 
- Hepatic impairment (Child Pugh B, C) or chronic renal insufficiency (creatinine > 2.5 mg/dl) and /or requirement of dialysis
- Clinically relevant bleedings disorders or conditions with increased risk for hemorrhages (active ulcers, trauma etc.)
- Addition or dose change of PAH specific drug treatments such as ERA or PDE5 inhibitors within 3 months before screening, or addition or dose change of non-specific treatments for PAH such as calcium channel blockers, nitrates, digitalis, diuretics within 4 weeks before Screening, or any kind of prostanoid other than those mentioned in inclusion criteria within less than 5 half-lives before treatment

Trial Summary

Enrollment Goal
27
Trial Dates
black-arrow
Phase
1/2
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Gießen, Germany, 35392

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
Locations

Investigative Site

Köln, Germany, 50924

Status
Completed
 
Locations

Investigative Site

Würzburg, Germany, 97067

Status
Completed
 
Locations

Investigative Site

München, Germany, 80639

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 

Trial Design