Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)
Information source: Hannover Medical School
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aerosolized iloprost (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Hannover Medical School Official(s) and/or principal investigator(s): Marius M Hoeper, MD, Study Chair, Affiliation: Hannover Medical School
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.
Clinical Details
Official title: Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 6 minute walk test
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hannover Medical School, Hannover 30625, Germany
Additional Information
Starting date: September 2004
Last updated: August 20, 2012
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