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Ventavis

Phase 3

Hypertension, Pulmonary | Small molecule | Cardiovascular |Bayer AG|Last Updated: Apr 20, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment134

FDA Designations

No designations recorded

Clinical trial landscape

Ventavis · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00185315Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary HypertensionHypertension, Pulmonary
COMPLETED71 Analytics
PHASE3COMPLETED
Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
Hypertension, Pulmonary
NCT0018531571
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Study Endpoints

Primary Endpoints

Adverse events
Throughout the whole study
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
Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange

Secondary Endpoints

Tolerability of treatment
Over a minimum of 24 months
Overall clinical tolerability of the long-term use of iloprost aerosol
Serious Adverse Events and deaths
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Ventavis (Iloprost, BAYQ6256)DRUGInhaled iloprost
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Eligibility Criteria

Age Range18 Years to 71 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Completion of the 12-week treatment period of the predecessor Schering study 97218/300180 * Investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient * Negative pregnancy test for females Exclusion Criteria: * Any condition dur...

Countries:BelgiumFranceItalyNetherlandsPolandPortugalSpain
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Frequently asked questions about Ventavis

What is Ventavis used for?

Ventavis is used for pulmonary hypertension, a condition of high blood pressure in the arteries of the lungs. It is an inhaled small molecule being developed by Bayer AG for this cardiovascular indication.

What does Ventavis target?

Ventavis targets the prostacyclin receptor, a G protein-coupled receptor that mediates vasodilation. By activating this receptor, Ventavis helps relax and widen blood vessels in the lungs, reducing pulmonary blood pressure.

Who makes Ventavis?

Ventavis is developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY.

What phase is Ventavis in?

Ventavis is in Phase 3 clinical development. It has completed two clinical trials, including a Phase 3 safety follow-up study and a Phase 2 long-term safety study, both in patients with pulmonary hypertension.

What clinical trials is Ventavis in?

Ventavis has completed two clinical trials: NCT00185315, a Phase 3 safety follow-up study of inhaled iloprost in 71 patients with pulmonary hypertension, and NCT00414687, a Phase 2 long-term safety study in 63 patients. Both trials are completed.

Is Ventavis the same as iloprost?

Yes, Ventavis is the brand name for iloprost, a prostacyclin analog. The clinical trials for Ventavis refer to it as inhaled iloprost, confirming that Ventavis and iloprost are the same drug.