NCT00425074

Pharmacodynamic-pharmacokinetic Trial, of Slow Release ASA, in the Platelet Functionalism.

Pharmacodynamic- Pharmacokinetic Trial, Comparative Double Blind, of the Chronic Administration of 150 mg of Slow Release ASA Versus 150 mg of Normal Release ASA, in the Platelet Functionalism.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Rottapharm Spain · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA: normal and the one of sustained release, in patients with stable coronary disease.

Detailed description

A large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication. Without doubt, the acetylsalicylic acid (ASA) is the most used antiaggregant product, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanism of action implicated, the association with other drugs, and the pharmaceutical form in order to improve the efficacy and the 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 of ASA.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	slow release acetyl salicylic acid	150 mg in capsules via oral, during 14 days.
DRUG	ASA	normal release acetylsalicylic acid
DRUG	SR-ASA	slow release acetylsalicylic acid 150 mg

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-06-01
• Completion: 2007-07-01
• First posted: 2007-01-22
• Last updated: 2011-06-08

Locations

1 site across 1 country: Spain