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.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2007
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJune 8, 2011
June 1, 2011
5 months
January 19, 2007
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To evaluate the principal kinetic parameters of both galenic formulations of ASA.
28 days
Study Arms (2)
SR-ASA
EXPERIMENTALslow release acetylsalicylic acid 150 mg
ASA
ACTIVE COMPARATORnormal release acetylsalicylic acid
Interventions
Eligibility Criteria
You may qualify if:
- Previous episodes of myocardial infarction
- Previous episodes of instable angina pectoris
- Previous coronary revascularization
- Significant arterial coronary disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rottapharm Spainlead
Study Sites (1)
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
MeSH Terms
Conditions
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 19, 2007
First Posted
January 22, 2007
Study Start
January 1, 2007
Primary Completion
June 1, 2007
Study Completion
July 1, 2007
Last Updated
June 8, 2011
Record last verified: 2011-06