Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310830
Status:
TERMINATED
Last Update Posted:
2010-02-15
First Post:
2006-04-03
Brief Title:
Efficacy and Safety of Bosentan in Sickle Cell Disease SCD Patients With Pulmonary Arterial Hypertension PAH
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Randomized Placebo-controlled Double-blind Multicenter Parallel Group Study to Assess the Efficacy Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease
Status:
TERMINATED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in sickle cell disease SCD patients diagnosed with pulmonary arterial hypertension It consists of 3 phases Screening Treatment and Follow-up During the Screening visit the study doctor will decide if patients meet the study requirements All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment Patients will be asked to perform exercise capacity test walking as far as possible for 6 minutes Following the Baseline visit the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated Patients will be treated for 16 weeks Blood samples will be collected every month or more often if needed At the end of the study patients will be asked to repeat the right heart catheterization and exercise capacity test After completion of the study patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ASSET-1 | None | None | None |