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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

Page last updated: August 23, 2015

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