check_circleStudy 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
  • - 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
  • - 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
July 1998 - May 2001
Phase
Phase 2
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

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
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    Safety Issue:
    None
  • Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange
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    Safety Issue:
    None

Secondary Outcome

  • Overall clinical tolerability of the long-term use of iloprost aerosol
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    Safety Issue:
    None
  • Serious Adverse Events and deaths
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    Safety Issue:
    None
  • Effect of long-term administration of inhaled iloprost on mortality and transplantation
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    Safety Issue:
    None
  • Exercise capacity
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    Safety Issue:
    None
  • Acute effect of inhaled iloprost on hemodynamics and gas exchange
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    Safety Issue:
    None
  • Effects of long-term administration of inhaled iloprost on hemodynamics and gas exchange
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    Safety Issue:
    None
  • Quality of Life
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    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
1

Additional Information

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