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

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ClinicalTrials.gov Identifier: NCT01355380
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

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.


Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: Inhaled iloprost (Ventavis, BAYQ6256)

Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".
Actual Study Start Date : August 5, 2010
Actual Primary Completion Date : April 28, 2016
Actual Study Completion Date : September 22, 2016


Group/Cohort Intervention/treatment
Group 1
Drug (incl. Placebo)
Drug: Inhaled iloprost (Ventavis, BAYQ6256)
Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily




Primary Outcome Measures :
  1. Changes of the exercise capacity as measured by 6-minutes walking distance [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]

Secondary Outcome Measures :
  1. Changes of depression score over time [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  2. Changes of functional capacity as measured by WHO classification system [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  3. Changes of pulmonary haemodynamics [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  4. Changes of serum level of natriuretic peptide B [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  5. Changes of Quality of Life score [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  6. Changes in cardiac echo parameters [ Time Frame: 3, 6, 9 and 12 months vs. baseline ]
  7. Number of patients with treatment-emergent adverse events [ Time Frame: Up to 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients prescribed Ventavis within the Pulmonary Arterial Hypertension Therapeutic Programme.
Criteria

Inclusion Criteria:

  • Pulmonary arterial hypertension in WHO functional class III or IV
  • Age 18+
  • Patients newly treated with Ventavis or switched from sildenafil

Exclusion Criteria:

  • Retrospective documentation is not allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355380


Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01355380     History of Changes
Other Study ID Numbers: 15308
VE1010PL ( Other Identifier: Company internal )
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by Bayer:
Pulmonary arterial hypertension
Inhaled iloprost
Quality of life

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents