Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT01188304
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of 150 µg Aleglitazar Once Daily in Healthy Subjects Treated With 325 mg Aspirin Once Daily on Renal Function, Renin-angiotensin System and Platelet Aggregation
Status:
COMPLETED
Status Verified Date:
2016-11
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:
None
Brief Summary:
This randomized, double-blind, placebo-controlled, parallel group study will investigate the safety and tolerability, and the effect of aleglitazar in combination with aspirin on renal function, renin-angiotensin system and platelet aggregation in healthy volunteers. Volunteers will be randomized to receive daily doses of aleglitazar or placebo in combination with aspirin. The anticipated time on study drug is 5 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: