Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin
NCT01785615
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- Women between the ages of 18-75 with Metabolic syndrome
- Abdominal circumference > 35 in
- Hypertriglyceridemia > 150mg/dl
- HDL <50
- Blood Pressure >130/85
- Fasting Glucose >100
- Pregnant or planning to become pregnant in the next 6-12 months
- Receiving lipid-lowing drugs
- Obstructive hepatobiliary disease or serious hepatic disease
- Diabetes, cardiovascular disease (CVD), hypothyroidism, active infection, cancer,
recent surgery
- Fulfill criteria to receive statin based on LDL levels, risk factors, and Framingham
risk scoring outlined on ATP111/NCEP 111 recommendations
- Documented allergic reaction to statin in past
- unexplained elevation in creatinine kinase levels > 3 times upper limit
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Descriptive Information | ||||
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Brief Title ICMJE | Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin | |||
Official Title ICMJE | Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin | |||
Brief Summary | Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood. The purpose of this study is two fold;
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Detailed Description | The first phase of the study is an observational phase as previously described. The second phase was a prospective evaluation of the effect of a well known "statin" drug (Lipitor) on different biochemical factors measured in the blood. The eligible study participants had blood work done upon enrollment and if criteria was met(according to the Adult Treatment Panel III), they were given dietary counseling (NYHA - New York Heart Association Step 1 diet) as a lead in phase. Lab work was repeated at 3 weeks to evaluate the impact of the diet and if participant's profile still met criteria for MBS,randomization for either atorvastatin (Lipitor) 80mg or placebo (sugar pill) for 12 weeks took place. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Metabolic Syndrome | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Velarde GP, Choudhary N, Bravo-Jaimes K, Smotherman C, Sherazi S, Kraemer DF. Effect of atorvastatin on lipogenic, inflammatory and thrombogenic markers in women with the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):634-640. doi: 10.1016/j.numecd.2020.10.002. Epub 2020 Oct 10. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 116 | |||
Original Estimated Enrollment ICMJE | 88 | |||
Actual Study Completion Date ICMJE | May 2013 | |||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01785615 | |||
Other Study ID Numbers ICMJE | Protocol No. 1988 Grant# 2004-1035 ( Other Grant/Funding Number: RSRB 29937 ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Gladys Velarde, University of Rochester | |||
Study Sponsor ICMJE | University of Rochester | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | University of Rochester | |||
Verification Date | April 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |