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NCT00760019 Clinical Trial

Inflammation and Vascular Function in Atherosclerosis

Atherosclerosis Clinical Trial

Official title:
Inflammation and Vascular Function in Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00760019
Other study ID # 2005P-001406
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 24, 2008
Last updated August 14, 2013
Start date August 2005
Est. completion date February 2011

Study information
Verified date August 2013
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date February 2011
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Non-smoking adult subjects with known atherosclerosis

Exclusion Criteria:

- Uncontrolled hypertension (> 140/90 mmHg)

- Untreated hypercholesterolemia (LDL > 160 mg/dL)

- Diabetes mellitus

- ALT > 150

- Creatinine > 1.4 mg/dL

- Concommitant use of warfarin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• salsalate
1.5 grams orally 3 times daily
• placebo
matching placebo

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in flow-mediated, endothelium-dependent vasodilation following 4 weeks of salsalate/placebo No
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