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Efficacy of Ventavis Used in Real-life Setting. (SPHERA)

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01355380
First received: May 17, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes

May 17, 2011
May 9, 2013
October 2010
October 2014   (final data collection date for primary outcome measure)
Changes of the exercise capacity as measured by 6-minutes walking distance [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
Changes of the exercise capacity as measured by 6-minutes walking distance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01355380 on ClinicalTrials.gov Archive Site
  • Changes of depression score over time [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
  • Changes of functional capacity as measured by WHO classification system [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
  • Changes of pulmonary haemodynamics [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
  • Changes of serum level of natriuretic peptide B [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
  • Changes of Quality of Life score [ Time Frame: 3, 6, 9 and 12 months vs. baseline ] [ Designated as safety issue: No ]
  • Changes of depression score over time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes of functional capacity as measured by WHO classification system [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes of pulmonary haemodynamics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes of serum level of natriuretic peptide B [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes of Quality of Life score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of Ventavis Used in Real-life Setting.
The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".

This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.

Typical clinical measures and quality of life will be prospectively followed in 12 months period.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Adult patients prescribed Ventavis within the Pulmonary Arterial Hypertension Therapeutic Programme.
Pulmonary Arterial Hypertension
Drug: Inhaled iloprost (Ventavis, BAYQ6256)
Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily
Group 1
Drug (incl. Placebo)
Intervention: Drug: Inhaled iloprost (Ventavis, BAYQ6256)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pulmonary arterial hypertension
  • Age 18+
  • Patients newly treated with Ventavis or switched from sildenafil

Exclusion Criteria:

  • Retrospective documentation is not allowed
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Poland
 
NCT01355380
15308, VE1010PL
No
Medical Director, Bayer Sp. z o.o. A. Jerozolimskie 158, Warsaw 02-326, Poland
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2013

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