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Efficacy of Ventavis Used in Real-life Setting.

NCT ID: NCT01355380

Last Updated: 2017-10-17

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

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-05

Study Completion Date

2016-09-22

Brief Summary

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This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.

Typical clinical measures and quality of life will be prospectively followed in 12 months period.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Keywords

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Pulmonary arterial hypertension Inhaled iloprost Quality of life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Drug (incl. Placebo)

Inhaled iloprost (Ventavis, BAYQ6256)

Intervention Type DRUG

Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily

Interventions

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Inhaled iloprost (Ventavis, BAYQ6256)

Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pulmonary arterial hypertension in WHO functional class III or IV
* Age 18+
* Patients newly treated with Ventavis or switched from sildenafil

Exclusion Criteria

* Retrospective documentation is not allowed
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Poland

Site Status

Countries

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Poland

Other Identifiers

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VE1010PL

Identifier Type: OTHER

Identifier Source: secondary_id

15308

Identifier Type: -

Identifier Source: org_study_id