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Sponsored by: |
ActivBiotics |
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Information provided by: | ActivBiotics |
ClinicalTrials.gov Identifier: | NCT00385385 |
The objective of this study is to evaluate an antibiotic therapy called Rifalazil to determine its effect on hardening of the carotid arteries.
Condition | Intervention | Phase |
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Coronary Artery Disease Cerebrovascular Disease Peripheral Vascular Disease |
Drug: Rifalazil |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Evaluation of Short-Term Rifalazil Treatment on Carotid Atherosclerosis and Intima Media Thickness |
Estimated Enrollment: | 72 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | September 2008 |
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 6,12 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.
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient meets at least one of the following criteria:
Exclusion Criteria:
Contact: Emelia Klonowski Klonowski | 914-289-1581 | eklonowski@activbiotics.com |
United States, Michigan | |
Thoracic & Cardiovascular Healthcare Foundation | Recruiting |
Lansing, Michigan, United States, 48910 | |
United States, New York | |
Stony Brook University Medical Center | Recruiting |
Stony Brook, New York, United States, 11794 | |
St. Francis Hospital | Recruiting |
Roslyn, New York, United States, 11576 | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Swedish Medical Center | Recruiting |
Seattle, Washington, United States, 98122 | |
Canada, Ontario | |
Robarts Research Institute | Recruiting |
London, Ontario, Canada |
Study ID Numbers: | ABI-1648-026 |
Study First Received: | October 6, 2006 |
Last Updated: | April 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00385385 |
Health Authority: | United States: Food and Drug Administration |
Arterial Occlusive Diseases Atherosclerosis Peripheral Vascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Central Nervous System Diseases Arteriosclerosis |
Ischemia Brain Diseases Cerebrovascular Disorders KRM 1648 Coronary Disease Chlamydia Infections Pneumonia Coronary Artery Disease |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Nervous System Diseases Cardiovascular Diseases |
Antitubercular Agents Pharmacologic Actions Leprostatic Agents Antibiotics, Antitubercular |