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

This study has been terminated.
(Futility analysis)
Information provided by:
Hannover Medical School Identifier:
First received: July 11, 2005
Last updated: August 20, 2012
Last verified: January 2006
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.

Condition Intervention Phase
Drug: Aerosolized iloprost
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension

Resource links provided by NLM:

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 6 minute walk test

Enrollment: 40
Study Start Date: September 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aerosolized Iloprost Drug: Aerosolized iloprost
Placebo Comparator: Bosentan monotherapy Drug: Placebo


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00120380

Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Study Chair: Marius M Hoeper, MD Hannover Medical School
  More Information

Publications: Identifier: NCT00120380     History of Changes
Other Study ID Numbers: COMBI
Study First Received: July 11, 2005
Last Updated: August 20, 2012

Keywords provided by Hannover Medical School:
Idiopathic pulmonary arterial hypertension

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents processed this record on May 25, 2017