Inflammation and Vascular Function in Atherosclerosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Brigham and Women's Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Brigham and Women's Hospital
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00760019
First received: September 24, 2008
Last updated: July 22, 2010
Last verified: July 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 24, 2008 | ||||||||
| Last Updated Date | July 22, 2010 | ||||||||
| Start Date ICMJE | August 2005 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in flow-mediated, endothelium-dependent vasodilation [ Time Frame: following 4 weeks of salsalate/placebo ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00760019 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Inflammation and Vascular Function in Atherosclerosis | ||||||||
| Official Title ICMJE | Inflammation and Vascular Function in Atherosclerosis | ||||||||
| Brief Summary | The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function. |
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| Detailed Description | To test the hypothesis that inhibition of I [kappa] B kinase [beta] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Atherosclerosis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | February 2011 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00760019 | ||||||||
| Other Study ID Numbers ICMJE | 2005P-001406 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Joshua Beckman, M.D., Principal Investigator, Brigham and Women's Hospital | ||||||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||||||
| Verification Date | July 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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