Pharmacodynamic Trial, of Slow Release ASA, in Platelet Functionalism, a

Status Completed

Clinical Trial Summary

Evaluation of the pharmacodynamic profile (antiaggregant profile, balance of prostanoids and nitric oxid) of a ASA-SR (slow-release)formulation in comparison with a ASA NR (normal release), 150 mg, during 12 months of treatment.

Clinical Trial Description

- A large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication.

- The acetylsalicylic acid (ASA) is the most used antiaggregant substance, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanisms of action implicated, the association with oder drugs, and the pharmaceutical fom in order to improve the efficacy and safety of the ASA.

- Some previous studies indicate that the slow release form of ASA has a different behaviour in the platelet effect in comparison with plain formulation.

- The aim of this study is to demonstrate the best antiaggregant and safety profile of a low dose of a slow release formulation in a long term treatment period of one year. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00501254
Study type	Interventional
Source	Rottapharm Spain
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	February 2005
Completion date	February 2007

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Pharmacodynamic Trial, of Slow Release ASA, in Platelet Functionalism, a Long Term Treatment Period

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms