Ignite Creation Date:
2024-05-05 @ 10:11 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01059682
Status:
TERMINATED
Last Update Posted:
2020-03-24
First Post:
2010-01-29
Brief Title:
A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multi-Center Double-blind Randomized Placebo Controlled Parallel Group Study of the Effect of Dalcetrapib on Atherosclerotic Disease Progression As Measured by Coronary Intravascular Ultrasound Carotid B-Mode Ultrasound and Coronary Angiography
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Termination of the clinical development program by the Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multicenter double-blind randomized placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease Atherosclerotic disease progression will be measured 1 Coronary Intravascular Ultrasound IVUS Quantitative Coronary Angiography 2 Carotid B-Mode Ultrasound Intima Medial Thickness IMT and total plaque volume in subjects undergoing coronary angiography who have coronary artery disease CAD Patients will be randomized to receive dalcetrapib 600 mg orally once a day or placebo The anticipated time on study treatment will be 24 months The target sample size is 800-1000 patients
Detailed Description:
None
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