Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385385
Status:
UNKNOWN
Last Update Posted:
2007-04-30
First Post:
2006-10-06
Brief Title:
RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease
Sponsor:
ActivBiotics
Organization:
ActivBiotics
Study Overview
Official Title:
Randomized Evaluation of Short-Term Rifalazil Treatment on Carotid Atherosclerosis and Intima Media Thickness
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate an antibiotic therapy called Rifalazil to determine its effect on hardening of the carotid arteries
Detailed Description:
To evaluate the effect of treatment with rifalazil versus placebo taken once weekly for 12 weeks on carotid atherosclerotic disease progression in patients who test positive for Chlamydia pneumoniae Measurements of the carotid artery wall intima-media thickness and plaque characteristics will be evaluated with high-resolution magnetic resonance imaging MRI and carotid ultrasound at Baseline and at 612 and 18 months following initiation of drug treatment in Chlamydia pneumoniae seropositive patients with a history of atherosclerotic disease Biomarkers will be collected throughout the study Safety will be evaluated by the collection and analysis of laboratory parameters vital signs electrocardiograms physical examination and adverse events Seventy two patients will be enrolled in this study There will be a total of approximately 7-9 visits which will occur over an 18 month period
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