check_circleStudy Completed

Pulmonary arterial hypertension

Bayer Identifier:

15308

ClinicalTrials.gov Identifier:

NCT01355380

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy of Ventavis used in real-life setting.

Trial purpose

This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.
Typical clinical measures and quality of life will be prospectively followed in 12 months period.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Pulmonary arterial hypertension in WHO functional class III or IV
    - Age 18+
    - Patients newly treated with Ventavis or switched from sildenafil


  • - Retrospective documentation is not allowed

Trial summary

Enrollment Goal
55
Trial Dates
August 2010 - September 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland

Primary Outcome

  • Changes of the exercise capacity as measured by 6-minutes walking distance
    date_rangeTime Frame:
    3, 6, 9 and 12 months vs. baseline
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    Safety Issue:
    No

Secondary Outcome

  • Changes of depression score over time
    date_rangeTime Frame:
    3, 6, 9 and 12 months vs. baseline
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    Safety Issue:
    No
  • Changes of functional capacity as measured by WHO classification system
    date_rangeTime Frame:
    3, 6, 9 and 12 months vs. baseline
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    Safety Issue:
    No
  • Changes of pulmonary haemodynamics
    date_rangeTime Frame:
    3, 6, 9 and 12 months vs. baseline
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    Safety Issue:
    No
  • Changes of serum level of natriuretic peptide B
    date_rangeTime Frame:
    3, 6, 9 and 12 months vs. baseline
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    Safety Issue:
    No
  • Changes of Quality of Life score
    date_rangeTime Frame:
    3, 6, 9 and 12 months vs. baseline
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    Safety Issue:
    No
  • Changes in cardiac echo parameters
    date_rangeTime Frame:
    3, 6, 9 and 12 months vs. baseline
  • Number of patients with treatment-emergent adverse events
    date_rangeTime Frame:
    Up to 12 months

Trial design

The efficacy of inhaled iloprost in patients treated within the “Pulmonary Arterial Hypertension Therapeutic Programme”.
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

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