Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046319
Status:
COMPLETED
Last Update Posted:
2009-04-16
First Post:
2002-09-26
Brief Title:
Study of BSF 208075 Evaluating Exercise Capacity in Patients With Pulmonary Arterial Hypertension
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase II Randomized Double-Blind Dose-Controlled Dose-Ranging Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Patients With Moderate to Severe Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if treating patients suffering from moderate to severe pulmonary arterial hypertension with BSF 208075 will improve the patients ability to exercise
Detailed Description:
This is a randomized double-blind study evaluating the effectiveness of BSF 208075 in treating patients with moderate to severe pulmonary hypertension A four-week Screening Period will be followed by 12 weeks of Treatment After a subject qualifies for the study the subject will be randomized to one of four doses of BSF 208075 10 25 50 or 100 mg po qd Subjects randomized to the 10 or 25 mg dose groups will receive their respective doses of BSF 208075 each day throughout the 12-week Treatment Period Subjects in the two other dose groups will begin treatment at 25 mg per day for two weeks and then their dose will be increased to 50 mg for an additional two weeks After two weeks of treatment at 50 mg subjects randomized to the 100 mg dose group will undergo a final up-titration After reaching the randomized dose level subjects will receive their assigned dose throughout the Treatment Period Subjects will remain on the randomized treatment through Week 12 In the event that a subject is not tolerating study drug dose adjustment is permitted during the Treatment Period Upon completion of the 12-week Treatment Period subjects will either complete a four-week Down-titration Period or enter an optional 12-week Open-label Extension All subjects that choose to participate in the Open-label Extension will be unblinded and have their dose of BSF 208075 optimized based on the subjects response during the Treatment Period
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