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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01355380
First received: May 17, 2011
Last updated: November 24, 2016
Last verified: November 2016
May 17, 2011
November 24, 2016
August 2010
April 2016   (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 ]
Changes of the exercise capacity as measured by 6-minutes walking distance [ Time Frame: 12 months ]
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 ]
  • Changes of functional capacity as measured by WHO classification system [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  • Changes of pulmonary haemodynamics [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  • Changes of serum level of natriuretic peptide B [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  • Changes of Quality of Life score [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  • Changes of depression score over time [ Time Frame: 12 months ]
  • Changes of functional capacity as measured by WHO classification system [ Time Frame: 12 months ]
  • Changes of pulmonary haemodynamics [ Time Frame: 12 months ]
  • Changes of serum level of natriuretic peptide B [ Time Frame: 12 months ]
  • Changes of Quality of Life score [ Time Frame: 12 months ]
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.
 
Completed
52
September 2016
April 2016   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01355380
15308
VE1010PL ( Other Identifier: Company internal )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2016

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