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

Phase 4

Terminated

• Conditions: Hypertension
• Interventions: Drug: Aerosolized iloprost; Drug: Placebo

• Registration Number: NCT00120380
• Lead Sponsor: Hannover Medical School

Brief Summary

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

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-07-11
• Study First Submitted QC: 2005-07-15
• Study First Posted: 2005-07-18
• Status Verified: 2006-01
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Last Update Submitted: 2012-08-20
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerosolized Iloprost	Aerosolized iloprost	-
Bosentan monotherapy	Placebo	-

Primary Outcome Measures

Name	Time	Method
6 minute walk test

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany