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

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ClinicalTrials.gov Identifier: NCT00425074
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Rottapharm Spain

Tracking Information
First Submitted Date  ICMJE January 19, 2007
First Posted Date  ICMJE January 22, 2007
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE January 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2007)
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
Change History Complete list of historical versions of study NCT00425074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2007)
To evaluate the principal kinetic parameters of both galenic formulations of ASA. [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2007)
To evaluate the principal kinetic parameters of both galenic formulations of ASA.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2007)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00425074
Other Study ID Numbers  ICMJE TROM-EC-ECC-FIb
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rottapharm Spain
Collaborators  ICMJE Not Provided
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
PRS Account Rottapharm Spain
Verification Date June 2011

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