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

Sponsor

Rottapharm Spain (Industry)

Overall Status

Completed

CT.gov ID

NCT00425074

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: slow release acetyl salicylic acid Drug: ASA Drug: SR-ASA	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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.

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SR-ASA slow release acetylsalicylic acid 150 mg	Drug: slow release acetyl salicylic acid 150 mg in capsules via oral, during 14 days. Drug: SR-ASA slow release acetylsalicylic acid 150 mg
Active Comparator: ASA normal release acetylsalicylic acid	Drug: ASA normal release acetylsalicylic acid

Arm

Intervention/Treatment

Experimental: SR-ASA

slow release acetylsalicylic acid 150 mg

Drug: slow release acetyl salicylic acid

150 mg in capsules via oral, during 14 days.

Drug: SR-ASA

slow release acetylsalicylic acid 150 mg

Active Comparator: ASA

normal release acetylsalicylic acid

Drug: ASA

normal release acetylsalicylic acid

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Previous episodes of myocardial 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Virgen de la Victoria	Málaga		Spain	29010

Sponsors and Collaborators

Rottapharm Spain

Investigators

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