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

Sponsor:	Rottapharm Spain
Information provided by:	Rottapharm Spain
ClinicalTrials.gov Identifier:	NCT00425074

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 I

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:

Drug Information available for: Acetylsalicylic acid Salicylic acid

U.S. FDA Resources

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

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 12, 2012