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PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease

2014-08-27 03:39:18 | BioPortfolio

Summary

The study will be conducted at up to 80 centers worldwide and will be a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (CAD). Subjects will be randomized to receive either placebo tablets or one of 4 orally active doses of A-002. The duration of study drug therapy will be 8 weeks.

Description

A-002 represents a novel therapy for the treatment of atherosclerosis and coronary artery disease (CAD). Through the inhibition of activity A-002 may provide multifunctional activity directed against key facets of the disease process, namely a) inflammation, b) atherogenic lipid profiles and c) the atherosclerotic process. Non-clinical and clinical data from recent studies have demonstrated the benefit of early and aggressive anti-inflammatory therapy to reduce cardiovascular risk. Recent clinical studies have provided a strong association between levels and cardiovascular event risk. The proposed Phase 2 clinical pharmacology study (Study No. AN-CVD-2221) will examine the effects of 4 different doses of A-002 compared with placebo, on enzyme levels and activity after 8 weeks of treatment. In addition, the effect of treatment on inflammatory markers of cardiovascular risk (C-reactive protein [CRP]), lipid levels and lipoprotein subclasses and other soluble biomarkers (e.g., ICAM-1, VCAM-1, TNF, MCP-1 etc) will also be assessed.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Conditions

Coronary Artery Disease (CAD)

Intervention

A-002

Location

Mobile Heart Specialists
Mobile
Alabama
United States
36608

Status

Completed

Source

Anthera Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:18-0400

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