Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01425359
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2011-08-24
Brief Title:
Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina
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:
COMPLETED
Status Verified Date:
2014-10
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:
TERISA
Brief Summary:
This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease CAD who have a history of type 2 diabetes mellitus T2DM and whether ranolazine can reduce the frequency of angina chest pain attacks compared to a placebo Subjects will be asked to record their daily angina episodes in a diary at the end of each study day Ranolazine is approved for the treatment of chronic angina and is not approved for the treatment of T2DM
Detailed Description:
Participants who meet the eligibility criteria at screening will enter a 4-to 6-week Qualifying Period The allowed concomitant antianginal medications must be maintained at a stable dose throughout the study Participants will document the number of angina episodes number of sublingual nitroglycerin doses taken and a dyspnea score on a scale from 1 to 5 on a daily basis in a diary Participants eligible to stay in the study after the Qualifying Period will enter the 8-week double-blind dosing phase Participants will have study visits at the end of Weeks 2 and 8 Participants will continue to document the number of angina episodes and number of sublingual nitroglycerin doses taken as well as a dyspnea score on a daily basis by the end of each day in their diary In addition participants will be called during Week 2 and at the end of Week 5 to encourage compliance A safety follow-up phone call will be made 14 days after the last study visit or early discontinuation
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