Trial Condition(s):

Hypertension, Pulmonary

Aerosolized Randomized Iloprost Study II (AIR - II) Long-term safety, tolerability, and clinical effects of iloprost inhalation in patients with primary or secondary pulmonary hypertension

Bayer Identifier:

90427

ClinicalTrials.gov Identifier:

NCT00414687

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to determine whether the study drug is effective in the long-term treatment of primary or secondary pulmonary hypertension

Inclusion Criteria
- Male or female patients
 - Secondary pulmonary hypertension
 - Mean pulmonary artery pressure equal or above 40 mmHg or primary pulmonary hypertension with a pressure equal or above 30 mmHg while resting during appropriate conventional treatment
 - Written informed consent after having been duly informed about all diagnostic and therapeutic measures involved in the study
Exclusion Criteria
- Clinical Instability at baseline
 - Pulmonary venous obstruction
 - Global respiratory insufficiency
 - Obstructive ventilation disorders, Interstitial pulmonary disease
 - Cerebrovascular events
 - Myocardial infarction or major cardiac surgery within 3 months prior to baseline
 - Bleeding disorders or bleeding risk
 - Severe hepatic insufficiency or renal insufficiency
 - Malignant diseases
 - HIV positive
 - Pregnancy, female patients of child-bearing potential without adequate contraception and nursing mothers
 - Congenital or acquired valvular defects and myocardial function disorders not related to pulmonary hypertension
 - Prior pulmonary embolism
 - Collagenosis
 - Pulmonary arterial or valvular stenosis

Trial Summary

Enrollment Goal
63
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

Trial Design