check_circleStudy Completed

Pulmonary Hypertension

Bayer Identifier:

14990

ClinicalTrials.gov Identifier:

NCT01389271

EudraCT Number:

Not Available

EU CT Number:

Not Available
Inhaled Iloprost in the treatment of patients with pulmonary hypertension up to 4 years

Trial purpose

This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Patients who has pulmonary hypertension treated with inhaled iloprost older than 18 years old.
    - Primary (idiopathic and familial) pulmonary hypertension (PH) with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
    - Pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
    - Patients who signed written informed consent.

  • - Severe coronary heart disease or unstable angina; Myocardial infarction within the last six months; Decompensated cardiac failure if not under close medical supervision;
    - Severe arrhythmias;
    - Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
    - Pulmonary hypertension due to venous occlusive disease.
    - Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
    - Pregnancy and lactation
    - Age below 18

Trial summary

Enrollment Goal
118
Trial Dates
February 2011 - June 2018
Phase
N/A
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Turkey

Primary Outcome

  • 6 Minutes walking distance (change in meters)
    date_rangeTime Frame:
    At month 48
    enhanced_encryption
    Safety Issue:
    No
  • Adverse events, weight, vital findings
    date_rangeTime Frame:
    At month 48
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • 6 Minutes walking distance (% change)
    date_rangeTime Frame:
    At month 48
    enhanced_encryption
    Safety Issue:
    No
  • New York Heart Association Functional Class
    date_rangeTime Frame:
    At month 48
    enhanced_encryption
    Safety Issue:
    No
  • Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change
    date_rangeTime Frame:
    At month 48
    enhanced_encryption
    Safety Issue:
    No
  • Pulmonary hypertension related hospitalization
    date_rangeTime Frame:
    At month 48
    enhanced_encryption
    Safety Issue:
    No
  • Heart and/or lung transplantation, mortality
    date_rangeTime Frame:
    At month 48
    enhanced_encryption
    Safety Issue:
    No

Trial design

Open-label, uncontrolled, prospective long-term observation of Inhaled Iloprost in the treatment of patients with pulmonary hypertension up to 4 years
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.