Study Completed

Hypertension, Pulmonary

Bayer Identifier:

90427

ClinicalTrials.gov Identifier:

NCT00414687

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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

Key Participants Requirements

Sex

Both

Age

18 - 70 Years

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

Trial Dates

July 1998 - May 2001

Phase

Phase 2

Could I Receive a placebo

Products

Ventavis (Iloprost, BAYQ6256)

Accepts Healthy Volunteer

Primary Outcome

Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange
Safety Issue:
None
Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange
Safety Issue:
None

Secondary Outcome

Overall clinical tolerability of the long-term use of iloprost aerosol
Safety Issue:
None
Serious Adverse Events and deaths
Safety Issue:
None
Effect of long-term administration of inhaled iloprost on mortality and transplantation
Safety Issue:
None
Exercise capacity
Safety Issue:
None
Acute effect of inhaled iloprost on hemodynamics and gas exchange
Safety Issue:
None
Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
Safety Issue:
None
Quality of Life
Safety Issue:
None

Trial design

An explorative, open-label, multicenter, randomized, parallel-group comparative study of safety, tolerability, and the clinical effects of iloprost inhalation in patients with primary or secondary pulmonary hypertension over 2 years

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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