Pharmacodynamic-Pharmacokinetic Trial, of Slow Release ASA, in the Platelet Functionalism. - Tabular View

Tracking Information

First Received Date ^ICMJE

January 19, 2007

Last Updated Date

July 13, 2007

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To evaluate the effect of the treatment with ASA (150 mg) produces on the tromboxan/prostacyclin balance and its repercussion in the platelet aggregation,comparing this effect between two formulations [ Time Frame: 28 days ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00425074 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the principal kinetic parameters of both galenic formulations of ASA. [ Time Frame: 28 days ]

Original Secondary Outcome Measures ^ICMJE

To evaluate the principal kinetic parameters of both galenic formulations of ASA.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Cardiovascular Disease

Intervention ^ICMJE

Drug: slow release acetyl salicylic acid
Behavioral: antithrombotic effect

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Previous episodes of miocardial infarction
Previous episodes of instable angina pectoris
Previous coronary revascularization
Significant arterial coronary disease

Exclusion Criteria:

Patients with other pathologies that requires treatment with other antiaggregants
Patients in treatment with low molecular weight heparin or oral anticoagulant
Patients with antecedents of hypersensibility to ASA

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00425074

Responsible Party

Study ID Numbers ^ICMJE

TROM-EC-ECC-FIb, EudraCT number:2006-002357-74

Study Sponsor ^ICMJE

Madaus, S.A.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Eloy Rueda, MD	Hosp. Universitario Virgen de la Victoria, Málaga (Spain)
Principal Investigator:	José Pedro de la Cruz, PhD	Departmento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
Principal Investigator:	José Antonio González Correa, PhD	Departamento de Farmacología y Terapéutica Clínica Facultad de Medicna, Universidad de Málaga

Information Provided By

Madaus, S.A.

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP