|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00909337 |
|
Date of registration:
|
27/05/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Early Therapy of Pulmonary Arterial Hypertension
|
|
Scientific title:
|
Early Therapy of Pulmonary Arterial Hypertension |
|
Date of first enrolment:
|
January 2008 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00909337 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Austria
| | | | | | | |
|
Contacts
|
|
Name:
|
Horst Olschewski, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Medical University of Graz |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- exercise-induced pulmonary hypertension
- systemic sclerosis
Exclusion Criteria:
- relevant pulmonary obstruction or restriction
- relevant left cardiac disease
- recent changes in medical therapy
- recent major operations
- recent major cardiovascular diseases
- inability to perform exercise
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Systemic Sclerosis
|
|
Pulmonary Hypertension
|
|
Intervention(s)
|
|
Drug: Bosentan
|
|
Primary Outcome(s)
|
|
Change of mean pulmonary arterial pressure at 50W under therapy with Bosentan compared to change of mean pulmonary arterial pressure at 50W before the introduction of therapy with Bosentan
[Time Frame: 12months before Bosentan therapy vs. at begin of bosentan therapy vs. 6months under bosentan therapy]
|
|
Secondary Outcome(s)
|
|
pulmonary vascular resistance, peak oxygen uptake
[Time Frame: 12months before Bosentan therapy vs. at begin of bosentan therapy vs. 6months under bosentan therapy]
|
|
Secondary ID(s)
|
|
18-295 ex 06/07
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|