Back to resultsCombination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)
Primary Purpose
Hypertension
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Aerosolized iloprost
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Idiopathic pulmonary arterial hypertension
Eligibility 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
Sites / Locations
- Hannover Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aerosolized Iloprost
Bosentan monotherapy
Arm Description
Outcomes
Primary Outcome Measures
6 minute walk test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00120380
Brief Title
Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)
Official Title
Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Terminated
Why Stopped
Futility analysis
Study Start Date
September 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hannover Medical School
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Idiopathic pulmonary arterial hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerosolized Iloprost
Arm Type
Active Comparator
Arm Title
Bosentan monotherapy
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aerosolized iloprost
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
6 minute walk test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius M Hoeper, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17012628
Citation
Hoeper MM, Leuchte H, Halank M, Wilkens H, Meyer FJ, Seyfarth HJ, Wensel R, Ripken F, Bremer H, Kluge S, Hoeffken G, Behr J. Combining inhaled iloprost with bosentan in patients with idiopathic pulmonary arterial hypertension. Eur Respir J. 2006 Oct;28(4):691-4. doi: 10.1183/09031936.06.00057906.
Results Reference
result
Learn more about this trial
Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)
We'll reach out to this number within 24 hrs