check_circleStudy Completed

Hypertension, Pulmonary

Bayer Identifier:

18838

ClinicalTrials.gov Identifier:

NCT02826252

EudraCT Number:

Not Available

EU CT Number:

Not Available
Examination of Ventavis (Iloprost) inhalation behavior using the I-Neb AAD system in patients with pulmonary arterial hypertension when switching the Iloprost nebulizer solution for inhalation from 10 μg/mL (V10) to 20 μg/mL (V20)

Trial purpose

The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Patients aged ≥18 years at time of signing informed consent.
    - Patients, diagnosed with group 1 PAH.
    - Patients must be enrolled in the German Ventavis patient support program Ventaplus.
    - Patients who either already switched from V10 to V20 therapy or who agreed to do so according to their physician’s decision.
    - Patients must have been on V10 therapy for at least 2 weeks.
    - Written informed consent must be obtained.
  • - participation in other clinical or interventional study.

Trial summary

Enrollment Goal
64
Trial Dates
September 2016 - January 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Ventavis (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Germany

Primary Outcome

  • Inhalation frequencies on Iloprost 10 ug/mL and 20 ug/mL
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Session-wise doses delivered (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

VENTASWITCH, Examination of Ventavis® (Iloprost) inhalation behavior using the I-Neb® AAD® system in patients with pulmonary arterial hypertension when switching the Iloprost nebulizer solution for inhalation from 10 μg/mL (V10) to 20 μg/mL (V20)
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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