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

Cardiovascular Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425074
• Other study ID #: TROM-EC-ECC-FIb
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2007
• Last updated: June 7, 2011
• Start date: January 2007
• Est. completion date: July 2007

Study information

• Verified date: June 2011
• Source: Rottapharm Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• slow release acetyl salicylic acid
150 mg in capsules via oral, during 14 days.
• ASA
normal release acetylsalicylic acid
• SR-ASA
slow release acetylsalicylic acid 150 mg

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Victoria	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Rottapharm Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the principal kinetic parameters of both galenic formulations of ASA.		28 days	No