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NCT00624923 · ClinicalTrials.gov registry record · Phase 2
Targeting Inflammation Using Salsalate in CardioVascular Disease
A Phase 2 study of Coronary Artery Disease and Overweight, sponsored by Joslin Diabetes Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 340
- Enrollment target
- 5
- Study locations
NCT00624923 is a Phase 2 study of Coronary Artery Disease and Overweight that has completed, run by Joslin Diabetes Center. The registered enrollment target is 340 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (74% lower). The trial reports 5 study locations across 2 states.
The verdict
NCT00624923, a Phase 2 study of Coronary Artery Disease and Overweight, has completed, sponsored by Joslin Diabetes Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 340 participants
- Enrollment target
- 5
- Study locations
Study Summary
The hypothesis is that western lifestyle, with sedentary behaviors and caloric excess promote a chronic, subacute inflammatory state that participates in the development and progression of atherosclerosis. We will evaluate the effects of targeting inflammation using the anti-inflammatory drug salsalate, compared to placebo, on coronary artery plaque volume assessed by multi-detector computed tomographic angiography (MDCTA). The TINSAL-CVD study is a randomized, double-masked, placebo-controlled, 2 arm, clinical trial. The purpose of the study is to compare the effect of salsalate or placebo on sub-acute inflammation and coronary plaque, in people with cardiovascular disease. Participants are randomized to active intervention (salsalate) or placebo interventions for a period of 30 months. The primary endpoint is change in plaque volume in the coronary arteries assessed by MDCTA from baseline to 30 months.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Salsalate
Study Locations (5)
Massachusetts
- Joslin Diabetes Center - Boston
- Heart Center of Metrowest - Framingham
- South Shore Internal Medicine - Milton
- Newton-Wellesley Cardiology - Newton
Maine
- Seacoast Cardiology - York Village
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2008-09 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00624923
The ClinicalTrials.gov registry entry for NCT00624923 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (74% lower). The listed sponsor is Joslin Diabetes Center, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00624923 reports 5 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Maine.
Frequently Asked Questions
What is clinical trial NCT00624923 about?
NCT00624923 is a clinical study titled "Targeting Inflammation Using Salsalate in CardioVascular Disease". The hypothesis is that western lifestyle, with sedentary behaviors and caloric excess promote a chronic, subacute inflammatory state that participates in the development and progression of atherosclerosis. We will evaluate the effects of targeting inflammation using the anti-inflammatory drug salsal...
What is the current status of trial NCT00624923?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 340 participants. The study started on 2008-09. Estimated completion is 2016-07.
What conditions does trial NCT00624923 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Overweight.
What interventions are being tested in trial NCT00624923?
The interventions under investigation include: Placebo (DRUG), Salsalate (DRUG).
Who is sponsoring clinical trial NCT00624923?
This trial is sponsored by Joslin Diabetes Center, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00624923 being conducted?
This trial has 5 study locations across Maine, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.