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

NCT00425074 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-06-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Rottapharm Spain

    lead INDUSTRY

Principal Investigators

  • Eloy Rueda, MD · Hosp. Universitario Virgen de la Victoria, Málaga (Spain)

  • José Pedro de la Cruz, PhD · Departmento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga

  • José Antonio González Correa, PhD · Departamento de Farmacología y Terapéutica Clínica Facultad de Medicna, Universidad de Málaga

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-06-30
Completion
2007-07-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00425074 on ClinicalTrials.gov