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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
  Purpose

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 Intervention
Pulmonary Arterial Hypertension
 Drug: Inhaled iloprost (Ventavis, BAYQ6256)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".

Resource links provided by NLM:

Drug Information available for: Iloprost
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • Age 18+
  • Patients newly treated with Ventavis or switched from sildenafil

Exclusion Criteria:

  • Retrospective documentation is not allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355380

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Sp. z o.o. A. Jerozolimskie 158, Warsaw 02-326, Poland
ClinicalTrials.gov Identifier: NCT01355380     History of Changes
Other Study ID Numbers: 15308, VE1010PL
Study First Received: May 17, 2011
Last Updated: May 9, 2013
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013