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

• Status: Completed
• Trial end date: 2001-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Iloprost

Criteria

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