Trials / Terminated
TerminatedNCT00902603
Ventavis® Registry Protocol
Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 148 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.
Detailed description
The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH and who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. All data will be collected via patient interview and/or review of the medical record, as well as from I-neb® downloads using INSIGHT software. Adherence with Ventavis® will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee, as well as before and after participation in PAH patient support groups (if applicable). Quarterly data collection will include capture of PAH and non-PAH medications and Ventavis® adherence data; Ventavis® adherence data will also be collected one month after study entry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Commercial Ventavis® (iloprost) | Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6) |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2009-05-15
- Last updated
- 2025-02-03
Source: ClinicalTrials.gov record NCT00902603. Inclusion in this directory is not an endorsement.