Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-01-01 @ 4:06 AM
Study NCT ID:
NCT01004705
Status:
TERMINATED
Last Update Posted:
2012-08-31
First Post:
2009-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol
Sponsor:
Ferrer Internacional S.A.
Organization:
Study Overview
Official Title:
Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Study of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril in Subjects With Elevated LDL Cholesterol
Status:
TERMINATED
Status Verified Date:
2012-07
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:
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: