Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501254
Status:
COMPLETED
Last Update Posted:
2007-07-18
First Post:
2007-07-13
Brief Title:
Pharmacodynamic Trial of Slow Release ASA in Platelet Functionalism a Long Term Treatment Period
Sponsor:
Rottapharm Spain
Organization:
Rottapharm Spain
Study Overview
Official Title:
Randomised Clinical Trial Parallel Double Blind to Evaluate the Influence of the ASA-SR Slow-Release in the Platelet Parameters and the Oxidative Status in Patients With Coronary Disease of Chronic Evolution During 12 Months
Status:
COMPLETED
Status Verified Date:
2007-07
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:
Evaluation of the pharmacodynamic profile antiaggregant profile balance of prostanoids and nitric oxid of a ASA-SR slow-releaseformulation in comparison with a ASA NR normal release 150 mg during 12 months of treatment
Detailed Description:
A large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy stroke and intermittent claudication
The acetylsalicylic acid ASA is the most used antiaggregant substance nevertheless and spite of being centenarian it last some questions pending regarding the most appropriate dose mechanisms of action implicated the association with oder drugs and the pharmaceutical fom in order to improve the efficacy and 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 in a long term treatment period of one year
The acetylsalicylic acid ASA is the most used antiaggregant substance nevertheless and spite of being centenarian it last some questions pending regarding the most appropriate dose mechanisms of action implicated the association with oder drugs and the pharmaceutical fom in order to improve the efficacy and 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 in a long term treatment period of one year
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT number 2004-000398-76 | None | None | None |