Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00303459
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2006-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)
Sponsor:
Actelion
Organization:
Study Overview
Official Title:
Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Compass-2
Brief Summary:
COMPASS-2 is a Phase 4, prospective, randomized, double-blind, placebo-controlled, event-driven study evaluating the effect of bosentan on the time to first confirmed morbidity/mortality event in patients with symptomatic PAH already receiving sildenafil therapy. Patients must have been receiving doses of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to being randomized.
The study continued until the predefined target number of morbidity/mortality events was reached.
The study continued until the predefined target number of morbidity/mortality events was reached.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| COMPASS-2 | OTHER | Actelion Pharmaceuticals Ltd | View |