Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients (DAILY)
| Tracking Information | |||||
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| First Received Date ICMJE | January 22, 2013 | ||||
| Last Updated Date | May 8, 2013 | ||||
| Start Date ICMJE | May 2013 | ||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Compliance of Ventavis use for each subject assessed by the mean daily number of inhalations and mean daily dose of Ventavis. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01781052 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients | ||||
| Official Title ICMJE | DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients | ||||
| Brief Summary | This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients aged ≥18 years and diagnosed with PAH (Pulmonary Arterial Hypertension), WHO/NYHA functional class III, Group I of the Dana point Pulmonary Hypertension Classification and newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I-Neb AAD device for the application. |
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| Condition ICMJE | Pulmonary Arterial Hypertension | ||||
| Intervention ICMJE | Drug: Ventavis (Iloprost, BAYQ6256)
Initial dose: 2.5 µg per inhalation session; 6-9 inhalations/day. Dose can be increased to up to 5.0 µg per inhalation session. |
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| Study Group/Cohort (s) | Group 1
Intervention: Drug: Ventavis (Iloprost, BAYQ6256) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | November 2015 | ||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Key contra indications:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01781052 | ||||
| Other Study ID Numbers ICMJE | 16133, VE1210FR, 2011/00416 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Bayer | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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