- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00296803
PROCLAIM: Study Examining Effects of Clopidogrel Compared to Placebo on Inflammation in Subjects With Metabolic Syndrome
January 10, 2011 updated by: Sanofi
PROCLAIM: Pilot Study Examining Effects of Clopidogrel Compared to Placebo on Markers of Inflammation in Subjects With Metabolic Syndrome
The purpose of this study is to examine the effects of clopidogrel compared to placebo on markers of inflammation in subjects with metabolic syndrome who are receiving background therapy including low dose aspirin.
Study Overview
Study Type
Interventional
Enrollment
216
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women at least 18 years old
- Women must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception and must agree to use an effective method of contraception throughout the study.
- Subject must meet 3 of the 5 National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATP III) criteria for the classification of metabolic syndrome: triglycerides >/= 150 mg/dL; blood pressure (BP): systolic blood pressure (SBP) >/= 130 mmHg/diastolic blood pressure (DBP) > 85 mmHg; fasting glucose >/= 110 mg/dL; waist circumference: men - > 101.6 cm (40 in)/women - > 88.9 cm (35 in); high-density lipoprotein (HDL) cholesterol: men - < 40 mg/dL/women - < 50 mg/dL.
- Subject has high-sensitivity C-reactive protein (hs-CRP) levels of >/= 2.0 but <10.0 mg/L at the Screening Visit (Week -2).
- Current medication regimen must be stable for six (6) weeks, i.e. no initiation of new prescription medication nor change in dosage of any previously initiated medication within three months of entering this study.
- Subject is normally active and judged to be in good health, based on medical history, routine safety laboratory tests (Screening Visit, Week -2), and a brief physical examination (Week -2).
Exclusion Criteria:
- Intolerance or contraindication to the use of clopidogrel or aspirin.
- Thrombocytopenia as defined by platelet count < 100,000/mm3.
- Current use or use within the past 3 months of oral anticoagulants, or dipyridamole or thienopyridine (ticlopidine or open-label clopidogrel) or oral glucocorticoids.
- Daily aspirin in excess of 81 mg, or chronic use of non-steroidal anti-inflammatory agents.
- Use of oral hormone replacement therapy or oral contraceptives including transdermal patch.
- History of pathologic bleeding (i.e., peptic ulcer or intracranial hemorrhage).
- History of chronic inflammatory disease or any recent medical event(s) resulting in tissue injury, infection, or inflammation.
- Myocardial infarction, coronary artery bypass graft, or angioplasty within the 6 months prior to Screening.
- Uncontrolled hypertension (systolic blood pressure >/= 180 mmHg or diastolic blood pressure >/= 100 mmHg) at Screening.
- History or presence of cancer in the past 2 years, except for successfully resected basal cell carcinoma of the skin.
- Recent history (within the past 12 months) for alcohol or substance abuse.
- Currently taking another investigational study medication or has taken investigational study medication within 30 days prior to Screening Visit.
- Any condition the Investigator believes would interfere with evaluation of the subject, or which could put the subject at undue risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To assess the effects of clopidogrel + aspirin vs placebo + aspirin on hs-CRP, CD40-ligand, soluble P-selectin, and other selected biomarkers in subjects with metabolic syndrome and elevated hs-CRP levels at study baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Lisa Lilienthal, M.S., Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
February 23, 2006
First Submitted That Met QC Criteria
February 23, 2006
First Posted (Estimate)
February 27, 2006
Study Record Updates
Last Update Posted (Estimate)
January 11, 2011
Last Update Submitted That Met QC Criteria
January 10, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Disease
- Insulin Resistance
- Hyperinsulinism
- Syndrome
- Inflammation
- Metabolic Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Clopidogrel
Other Study ID Numbers
- L_9842
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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