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

NCT ID: NCT00414687

Last Updated: 2009-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-07-31
• Study Completion Date: 2001-05-31

Brief 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

Detailed 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.

Conditions

Hypertension, Pulmonary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Ventavis (Iloprost, BAYQ6256)

Intervention Type: DRUG

Interventions

Ventavis (Iloprost, BAYQ6256)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Schering Pharma AG

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

References

Olschewski H, Hoeper MM, Behr J, Ewert R, Meyer A, Borst MM, Winkler J, Pfeifer M, Wilkens H, Ghofrani HA, Nikkho S, Seeger W. Long-term therapy with inhaled iloprost in patients with pulmonary hypertension. Respir Med. 2010 May;104(5):731-40. doi: 10.1016/j.rmed.2010.01.008. Epub 2010 Feb 11.

Reference Type: DERIVED

PMID: 20153158 (View on PubMed)

Other Identifiers

300341

Identifier Type: -

Identifier Source: secondary_id

90427

Identifier Type: -

Identifier Source: org_study_id