Ventavis® Registry Protocol (RESPIRE)

This study has been terminated.
(low enrollment rate and difficulty in recruiting eligible patients in adequate time)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00902603
First received: May 13, 2009
Last updated: July 16, 2013
Last verified: July 2013

May 13, 2009
July 16, 2013
March 2009
December 2013   (final data collection date for primary outcome measure)
Adherence with instructions for use of Ventavis® [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00902603 on ClinicalTrials.gov Archive Site
Persistence of use of Ventavis® [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ventavis® Registry Protocol
Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary Care Clinic

Pulmonary Arterial Hypertension
Drug: Commercial Ventavis® (iloprost)
Commercial Ventavis® (iloprost) administered via portable nebulizer (I-neb® AAD® system using the power disc-6)
1
Patients with WHO Group I pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months.
Intervention: Drug: Commercial Ventavis® (iloprost)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
148
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have a current diagnosis of WHO Group I PAH
  2. Have initiated therapy with commercial Ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in Actelion's Clinical Study AC-063A302
  3. Age > or = 18 years old at the time of enrollment

Exclusion Criteria:

  1. Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH
  2. Are not currently on commercial Ventavis®
  3. Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00902603
AC-063A501
No
Actelion
Actelion
Not Provided
Not Provided
Actelion
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP