Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425074
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2007-01-19
Brief Title:
Pharmacodynamic-pharmacokinetic Trial of Slow Release ASA in the Platelet Functionalism
Sponsor:
Rottapharm Spain
Organization:
Rottapharm Spain
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with ASA 150 mg producescomparing 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None