Study 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

Inclusion Criteria
- 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.
Exclusion Criteria
- participation in other clinical or interventional study.

Trial summary

Enrollment Goal

Trial Dates

September 2016 - January 2017

Phase

Phase 4

Could I Receive a placebo

Products

Ventavis (Iloprost, BAYQ6256)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many locations, Germany

Primary Outcome

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

Secondary Outcome

Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL
Time Frame:
Up to 6 months
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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