Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01334203
Status:
WITHDRAWN
Last Update Posted:
2012-07-31
First Post:
2011-04-11
Brief Title:
A Study on the Effects of Ranolazine on Exercise Duration in Subjects With Chronic Stable Angina and Coronary Artery Disease CAD With Type 2 Diabetes Mellitus T2DM
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 4 Randomized Double-Blind Placebo-Controlled Parallel Study of Ranolazine in Subjects With Chronic Stable Angina and Coronary Artery Disease With a History of Type 2 Diabetes Mellitus
Status:
WITHDRAWN
Status Verified Date:
2012-07
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 study will evaluate the efficacy of ranolazine compared to placebo on duration of exercise assessed by exercise tolerance testing ETT at anticipated peak ranolazine plasma concentration after 12 weeks of treatment in subjects with chronic stable angina and coronary artery disease CAD who have a history of type 2 diabetes mellitus T2DM
Detailed Description:
This study will evaluate the efficacy of ranolazine compared to placebo on duration of exercise assessed by exercise tolerance testing ETT at anticipated peak ranolazine plasma concentration after 12 weeks of treatment in subjects with chronic stable angina and coronary artery disease CAD who have a history of type 2 diabetes mellitus T2DM This is a randomized double-blind placebo-controlled parallel group study in subjects with chronic stable angina and CAD receiving a stable dose of a single concomitant antianginal medication who also have a history of T2DM allowed antianginals will be a beta-blocker atenolol or metoprolol or a calcium-channel blocker
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