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

This study has been terminated.
(Futility analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120380
First Posted: July 18, 2005
Last Update Posted: August 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hannover Medical School
  Purpose
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
Hypertension Drug: Aerosolized iloprost Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120380


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

Publications:
ClinicalTrials.gov Identifier: NCT00120380     History of Changes
Other Study ID Numbers: COMBI
First Submitted: July 11, 2005
First Posted: July 18, 2005
Last Update Posted: August 21, 2012
Last Verified: January 2006

Keywords provided by Hannover Medical School:
Idiopathic pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Bosentan
Iloprost
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents


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