Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension

NCT ID: NCT00185315

Last Updated: 2010-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2005-08-31

Brief Summary

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The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

Detailed Description

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This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Conditions

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Hypertension, Pulmonary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Ventavis (Iloprost, BAYQ6256)

Intervention Type DRUG

Inhaled iloprost

Interventions

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Ventavis (Iloprost, BAYQ6256)

Inhaled iloprost

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completion of the 12-week treatment period of the predecessor Schering study 97218/300180
* Investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient
* Negative pregnancy test for females

Exclusion Criteria

* Any condition during 12-week treatment period of the predecessor Schering study 97218/300180 that prevents participation in the follow-up safety surveillance study
Minimum Eligible Age

18 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Schering Pharma AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Brussels, , Belgium

Site Status

Leuven, , Belgium

Site Status

Clamart, , France

Site Status

Grenoble, , France

Site Status

Lille, , France

Site Status

Reims, , France

Site Status

Tours, , France

Site Status

Bologna, BO, Italy

Site Status

Montescano, Pavia, Italy

Site Status

Pisa, PI, Italy

Site Status

Amsterdam, , Netherlands

Site Status

Warsaw, , Poland

Site Status

Coimbra, , Portugal

Site Status

Vila Nova de Gaia, , Portugal

Site Status

Barcelona, Barcelona, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Countries

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Belgium France Italy Netherlands Poland Portugal Spain

Other Identifiers

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303045

Identifier Type: -

Identifier Source: secondary_id

Follow-up 90419-300180

Identifier Type: -

Identifier Source: secondary_id

90570

Identifier Type: -

Identifier Source: org_study_id

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