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
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Drug: slow release acetyl salicylic acid
Drug: ASA
Drug: SR-ASA
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Rottapharm Spain:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To evaluate the principal kinetic parameters of both galenic formulations of ASA. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2007
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SR-ASA
slow release acetylsalicylic acid 150 mg
Drug: slow release acetyl salicylic acid
150 mg in capsules via oral, during 14 days.
Drug: SR-ASA
slow release acetylsalicylic acid 150 mg
Active Comparator: ASA
normal release acetylsalicylic acid
Drug: ASA
normal release acetylsalicylic acid

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425074

Locations
Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Sponsors and Collaborators
Rottapharm Spain
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00425074     History of Changes
Other Study ID Numbers: TROM-EC-ECC-FIb
Study First Received: January 19, 2007
Last Updated: June 7, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Rottapharm Spain:
slow release ASA
platelet functionalism
secondary cardiovascular prevention

Additional relevant MeSH terms:
Cardiovascular Diseases
Aspirin
Salicylic Acid
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antifungal Agents
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Dermatologic Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Keratolytic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014