Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00461058
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2007-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Randomized, Double Blind Study to Compare the Safety and Tolerability of Aleglitazar and Actos in Patients With Type 2 Diabetes and NYHA Class II Heart Failure.
Status:
COMPLETED
Status Verified Date:
2016-08
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 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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?: