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OpenTrials
Completed

NCT Number: NCT00250640

Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for 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.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Familial Primary Pulmonary Hypertension Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brest, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

    Time frame: Month 3 Visit

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Other safety variable

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

    Weight, vital signs, findings in PPH-related signs and symptoms, hospitalization because of PPH, incidence of heart and/or lung transplantation

  6. Other safety variables (optional assessment)

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

    Chest x-ray, electrocardiogram, findings of heart catheter test, findings of pulmonary function tests, findings of blood gas analyses

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Nov 8, 2005
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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