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Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00250640
First received: November 7, 2005
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.


Condition Intervention
Hypertension, Pulmonary
 Drug: Iloprost (Ventavis, BAYQ6256)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years

Resource links provided by NLM:

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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • The primary efficacy variable is 6-minute walking distance. Focus will lay on the individual changes (in meters) at Month 3 (after inhalation) compared to the value measured at baseline. [ Time Frame: Month 3 Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: No ]
  • Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: No ]
  • Mortality, defined as all-cause mortality, will be assessed for all patients included in this study. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: No ]
  • The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]
  • Other safety variable: weight. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]
  • Other safety variable: vital signs. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]
  • Other safety variable: Chest x-ray. [ Time Frame: optional assessment at all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]
  • Other safety variables: Electrocardiogram. [ Time Frame: optional assessment at all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 104
Study Start Date: April 2005
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Iloprost (Ventavis, BAYQ6256)
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser). Dosing should follow the recommendations of the current package leaflet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with the disease in scope and the prescription of Ventavis mainly from expert clinics in the participating countries

Criteria

Inclusion Criteria:

  • The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
  • Patient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA functional class III (NYHA = New York Heart Association)
  • No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma)

Exclusion Criteria:

  • Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis Summary of Product Characteristics and patient package insert)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250640

  Show 43 Study Locations
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 Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00250640     History of Changes
Other Study ID Numbers: 91430, 308120
Study First Received: November 7, 2005
Last Updated: May 2, 2012
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Federal Institute for Drugs and Medical Devices
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Italy: Ethics Committee

Keywords provided by Bayer:
Primary Pulmonary hypertension

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 22, 2013