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Ventavis

Phase 3FDA approved 2004

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

Ventavis development status

FDA approval Dec 29, 2004
Approval holderActelion
ApplicationNDA021779
Highest phase Phase 3
Registered trials 2 across 2 sponsors since Jul 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment134

FDA Designations

No designations recorded

Ventavis clinical trials

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, PulmonaryUnlock trial analytics

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 developed by Bayer AG under the ticker BAYRY. The clinical program studied patients with primary or secondary pulmonary hypertension, and the drug is given by inhalation.

Who makes Ventavis?

Ventavis is developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer sponsored the clinical trial program for the drug in pulmonary hypertension, including the AIR-II study and a long-term safety follow-up study conducted across several European countries.

What phase is Ventavis in?

Ventavis has been studied in Phase 3 clinical development for pulmonary hypertension. Two completed trials are registered, one Phase 2 study and one Phase 3 safety follow-up study, with a combined enrollment of 134 patients. No trials are currently listed as active.

What clinical trials is Ventavis in?

Two completed trials of Ventavis are registered. NCT00414687, the Aerosolized Randomized Iloprost Study II (AIR-II), was a Phase 2 trial in 63 patients with primary or secondary pulmonary hypertension. NCT00185315 was a Phase 3 safety follow-up study of inhaled iloprost in 71 patients, run in Belgium, France, Italy, Netherlands, Poland, Portugal and Spain.

Is Ventavis the same as iloprost?

Yes. Ventavis is the brand name for iloprost, and the compound is also identified by the code BAYQ6256. Searches for Ventavis, iloprost, or BAYQ6256 refer to the same inhaled small molecule developed by Bayer AG for pulmonary hypertension.

How was the Ventavis trial program designed?

The registered Ventavis studies enrolled adults 18 years and older of both sexes, and both were randomized. The Phase 2 AIR-II trial enrolled 63 patients and the Phase 3 safety follow-up study enrolled 71 patients. Neither study used a controlled design, and patients were not selected by biomarker.