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

This study has been completed.
Sponsor:
Information provided by:
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT00425074
First received: January 19, 2007
Last updated: June 7, 2011
Last verified: June 2011

January 19, 2007
June 7, 2011
January 2007
June 2007   (final data collection date for primary outcome measure)
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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00425074 on ClinicalTrials.gov Archive Site
To evaluate the principal kinetic parameters of both galenic formulations of ASA. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
To evaluate the principal kinetic parameters of both galenic formulations of ASA.
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Cardiovascular Disease
  • 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
  • Experimental: SR-ASA
    slow release acetylsalicylic acid 150 mg
    Interventions:
    • Drug: slow release acetyl salicylic acid
    • Drug: SR-ASA
  • Active Comparator: ASA
    normal release acetylsalicylic acid
    Intervention: Drug: ASA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00425074
TROM-EC-ECC-FIb
Not Provided
Not Provided
Rottapharm Spain
Not Provided
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
Rottapharm Spain
June 2011

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