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

Status and phase

Completed

Phase 2

Conditions

Hypertension, Pulmonary

Treatments

Drug: Ventavis (Iloprost, BAYQ6256)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00414687

90427

300341

Details and patient eligibility

About

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

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Enrollment

63 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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