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Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)

NCT ID: NCT00120380

Last Updated: 2012-08-21

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-05-31

Brief Summary

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The purpose of this study is to test whether the addition of inhaled iloprost is safe and effective in patients with idiopathic pulmonary arterial hypertension who are already being treated with the endothelin receptor antagonist bosentan.

Detailed Description

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Conditions

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Hypertension

Keywords

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Idiopathic pulmonary arterial hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aerosolized Iloprost

Group Type ACTIVE_COMPARATOR

Aerosolized iloprost

Intervention Type DRUG

Bosentan monotherapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Aerosolized iloprost

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* IPAH
* \> 3 months treatment with bosentan
* 6 minute walk distance 150 - 425 m

Exclusion Criteria

* other forms of pulmonary hypertension
* severe comorbidities
* cotreatment with sildenafil or investigational drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Principal Investigators

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Marius M Hoeper, MD

Role: STUDY_CHAIR

Hannover Medical School

Locations

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Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

References

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Hoeper MM, Leuchte H, Halank M, Wilkens H, Meyer FJ, Seyfarth HJ, Wensel R, Ripken F, Bremer H, Kluge S, Hoeffken G, Behr J. Combining inhaled iloprost with bosentan in patients with idiopathic pulmonary arterial hypertension. Eur Respir J. 2006 Oct;28(4):691-4. doi: 10.1183/09031936.06.00057906.

Reference Type RESULT
PMID: 17012628 (View on PubMed)

Other Identifiers

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COMBI

Identifier Type: -

Identifier Source: org_study_id