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

Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years

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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Drug: Iloprost (Ventavis, BAYQ6256)

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• France
  • Brest, France, F-29609
  • Clamart Cedex, France, 92141
  • Lille, France, 59037
  • Lyon Cedex 03, France, 69394
  • Pessac, France, 33604
  • Reims, France, 51092
  • Strasbourg, France, 67091
  • Vandoeuvre les Nancy Cedex, France, 54500
• Germany
  • Berlin, Germany, 12200
  • Berlin, Germany, 13353
  • Hamburg, Germany, 20246
  • Baden-Württemberg
    • Donaueschingen, Baden-Württemberg, Germany, 78166
    • Heidelberg, Baden-Württemberg, Germany, 69120
    • Heidelberg, Baden-Württemberg, Germany, 69126
    • Löwenstein, Baden-Württemberg, Germany, 74245
  • Bayern
    • Erlangen, Bayern, Germany, 91054
    • München, Bayern, Germany, 80336
    • München, Bayern, Germany, 81377
    • Regensburg, Bayern, Germany, 93053
  • Hessen
    • Gießen, Hessen, Germany, 35392
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53105
    • Essen, Nordrhein-Westfalen, Germany, 45147
    • Köln, Nordrhein-Westfalen, Germany, 50924
    • Mönchengladbach, Nordrhein-Westfalen, Germany, 41069
    • Wuppertal, Nordrhein-Westfalen, Germany, 42283
  • Saarland
    • Homburg/Saar, Saarland, Germany, 66421
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
    • Leipzig, Sachsen, Germany, 04103
  • Thüringen
    • Erfurt, Thüringen, Germany, 99089
• Italy
  • Bologna, Italy, 40138
  • Pavia, Italy, 27100
  • Pisa, Italy, 56100
  • Roma, Italy, 00161
• Portugal
  • Coimbra, Portugal, 3000-075
  • Lisboa, Portugal, 1150-291
• Spain
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08035
  • Córdoba, Spain, 14004
  • Madrid, Spain, 28041
• United Kingdom
  • Glasgow, United Kingdom, G11 6NT
  • London, United Kingdom, NW3 2PF
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
  • Sheffield, United Kingdom, S10 2JF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Month 3 Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.		all scheduled visits (Study period is min. 2 years and max. 4 years)
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.		all scheduled visits (Study period is min. 2 years and max. 4 years)
Mortality, defined as all-cause mortality, will be assessed for all patients included in this study.		all scheduled visits (Study period is min. 2 years and max. 4 years)
The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study.		all scheduled visits (Study period is min. 2 years and max. 4 years)
Other safety variable	Weight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantation	At all scheduled visits (Study period is min. 2 years and max. 4 years)
Other safety variables (optional assessment)	Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analyses	At all scheduled visits (Study period is min. 2 years and max. 4 years)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: November 7, 2005
• First Submitted That Met QC Criteria: November 7, 2005
• First Posted (Estimate): November 8, 2005

Study Record Updates

• Last Update Posted (Estimate): February 2, 2015
• Last Update Submitted That Met QC Criteria: January 30, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Primary Pulmonary hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: 91430; 308120 (Other Identifier: Company internal)