Long-term Observational Study of Ventavis in Pulmonary Hypertension - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00250640

Purpose

The aim of the study is to monitor the continued effectiveness of Ventavis (inhaled iloprost) for the treatment of primary pulmonary hypertension NYHA class III in the long-term.

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

Study Type:	Observational
Study Design:	Cohort, 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:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Iloprost

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary efficacy variables to 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: 6-minute walking distance at 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

6-minute walking distance versus baseline (improvement=increase of at least 10% / deterioration=decrease in 6-minute walking distance of at least 30%) [ Time Frame: Clinical stability of patients over minimum of 2 years ] [ Designated as safety issue: No ]
NYHA functional class [ Time Frame: Up to 4 years (over minimum of 2 years) ] [ Designated as safety issue: No ]
PPH-related previous and concomitant medications / Active treatments for PPH / Ventavis treatment [ Time Frame: Up to 4 years (over minimum of 2 years) ] [ Designated as safety issue: No ]
PPH related symtoms [ Time Frame: Up to 4 years (over minimum of 2 years) ] [ Designated as safety issue: No ]
PPH related hopitalization [ Time Frame: Up to 4 years (over minimum of 2 years) ] [ Designated as safety issue: No ]
Heart and/ or Lung Transplantation / Mortality [ Time Frame: Up to 4 years (over minimum of 2 years) ] [ Designated as safety issue: No ]
Hemodynamic catheter test, pulmonary function test and blood gas analyses (optional assessments) [ Time Frame: Up to 4 years (over minimum of 2 years) ] [ Designated as safety issue: No ]
Safety Measures [ Time Frame: Up to 4 years (over minimum of 2 years) ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

n.a.

Estimated Enrollment:	54
Study Start Date:	April 2005
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Arm 1	Drug: Iloprost (Ventavis, BAYQ6256) Ventavis as prescribed by the physician.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with PPH, classified as NYHA functional class III, where the treating physician has chosen Ventavis as a suitable long-term treatment prior to inclusion into this non-interventional study.

Criteria

Inclusion Criteria:

The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
Patient has primary pulmonary hypertension (i.e. familial pulmonary arterial hypertension or idiopathic pulmonary arterial hypertension)
Patient has provided written informed/data protection consent
No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of study inclusion

Exclusion Criteria:

Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250640

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

France
	Recruiting
Strasbourg, France, 67091
Germany
	Recruiting
Berlin, Germany, 13353
	Recruiting
Berlin, Germany, 12200
	Recruiting
Hamburg, Germany, 20251
Germany, Baden-Württemberg
	Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
	Active, not recruiting
Freiburg, Baden-Württemberg, Germany, 79106
	Recruiting
Löwenstein, Baden-Württemberg, Germany, 74245
	Recruiting
Heidelberg, Baden-Württemberg, Germany, 69126
Germany, Bayern
	Recruiting
Regensburg, Bayern, Germany, 93053
	Not yet recruiting
Erlangen, Bayern, Germany, 91054
Germany, Hessen
	Recruiting
Gießen, Hessen, Germany, 35392
Germany, Nordrhein-Westfalen
	Recruiting
Mönchengladbach, Nordrhein-Westfalen, Germany, 41069
	Recruiting
Köln, Nordrhein-Westfalen, Germany, 50931
	Not yet recruiting
Essen, Nordrhein-Westfalen, Germany, 45147
	Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53105
	Recruiting
Bochum, Nordrhein-Westfalen, Germany, 44789
Germany, Sachsen
	Recruiting
Dresden, Sachsen, Germany, 01307
	Recruiting
Leipzig, Sachsen, Germany, 04103
Germany, Thüringen
	Not yet recruiting
Erfurt, Thüringen, Germany, 99089
Italy
	Recruiting
Roma, Italy, 00161
Spain
	Recruiting
Barcelona, Spain, 08035
	Recruiting
Barcelona, Spain, 08036
	Recruiting
Córdoba, Spain, 14004
	Recruiting
Madrid, Spain, 28041

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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	91430
Study First Received:	November 7, 2005
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00250640 History of Changes
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

Keywords provided by Bayer:

Primary Pulmonary hypertension

Study placed in the following topic categories:

Iloprost
Vasodilator Agents
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Idiopathic Pulmonary Hypertension
Vascular Diseases
Platelet Aggregation Inhibitors
Cardiovascular Agents
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Hematologic Agents
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Iloprost
Respiratory Tract Diseases

Hypertension, Pulmonary
Lung Diseases
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009