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

NCT00250640 | Completed

• 2 other identifiers: 91430308120
• Study Type: observational
• Target: 106
• Locations: 6 countries
• Sites: 43

Brief Summary

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.

Conditions

Hypertension, Pulmonary

Keywords

Primary Pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  At all scheduled visits (Study period is min. 2 years and max. 4 years)

Study Arms (1)

Group 1

Drug: Iloprost (Ventavis, BAYQ6256)

Interventions

Iloprost (Ventavis, BAYQ6256) DRUG

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (43)

Unknown Facility

Brest, F-29609, France

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Clamart, 92141, France

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Lille, 59037, France

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Lyon, 69394, France

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Pessac, 33604, France

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Reims, 51092, France

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Strasbourg, 67091, France

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Vandœuvre-lès-Nancy, 54500, France

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Donaueschingen, Baden-Wurttemberg, 78166, Germany

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Heidelberg, Baden-Wurttemberg, 69126, Germany

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Löwenstein, Baden-Wurttemberg, 74245, Germany

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Erlangen, Bavaria, 91054, Germany

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München, Bavaria, 80336, Germany

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München, Bavaria, 81377, Germany

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Regensburg, Bavaria, 93053, Germany

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Hamburg, Hamburg, 20246, Germany

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Giessen, Hesse, 35392, Germany

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Bonn, North Rhine-Westphalia, 53105, Germany

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Cologne, North Rhine-Westphalia, 50924, Germany

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Essen, North Rhine-Westphalia, 45147, Germany

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Mönchengladbach, North Rhine-Westphalia, 41069, Germany

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Wuppertal, North Rhine-Westphalia, 42283, Germany

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Homburg/Saar, Saarland, 66421, Germany

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Dresden, Saxony, 01307, Germany

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Leipzig, Saxony, 04103, Germany

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Berlin, State of Berlin, 12200, Germany

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Berlin, State of Berlin, 13353, Germany

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Erfurt, Thuringia, 99089, Germany

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Bologna, 40138, Italy

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Pavia, 27100, Italy

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Pisa, 56100, Italy

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Roma, 00161, Italy

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Coimbra, Coimbra District, 3000-075, Portugal

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Lisbon, 1150-291, Portugal

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Barcelona, Barcelona, 08036, Spain

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Córdoba, Córdoba, 14004, Spain

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Barcelona, 08035, Spain

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Madrid, 28041, Spain

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Glasgow, G11 6NT, United Kingdom

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London, NW3 2PF, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Familial Primary Pulmonary Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 8, 2005
• Study Start: April 1, 2005
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

GB (4); ES (4); DE (21); IT (4); FR (8); PT (2)