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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:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00120380
First received: July 11, 2005
Last updated: August 20, 2012
Last verified: January 2006
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 11, 2005
Last Updated: August 20, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Idiopathic pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Bosentan
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 23, 2013