Ignite Creation Date:
2024-05-06 @ 12:05 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01485900
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2011-11-24
Brief Title:
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study to Evaluate the Safety Tolerability and Hemodynamics of Ascending Repeated Oral Doses of SAR407899A in Patients With Moderate Chronic Kidney Disease on Stable Angiotensin Converting Enzyme-inhibitor ACE-I Treatment
Status:
COMPLETED
Status Verified Date:
2012-08
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:
Primary Objective
To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in patients with moderate chronic kidney disease CKD on stable angiotensin converting enzyme-inhibitor ACE-I
Secondary Objectives
To assess in patients with moderate CKD the effect of concomitant multiple dose of SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate
The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to ACE-Is AcSDKP
The pharmacokinetic profile of repeated oral administration of SAR407899A during co-administration of ACE-Is
To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in patients with moderate chronic kidney disease CKD on stable angiotensin converting enzyme-inhibitor ACE-I
Secondary Objectives
To assess in patients with moderate CKD the effect of concomitant multiple dose of SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate
The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to ACE-Is AcSDKP
The pharmacokinetic profile of repeated oral administration of SAR407899A during co-administration of ACE-Is
Detailed Description:
The total duration for this study will be around 8 weeks
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 |
|---|---|---|---|
| U1111-1123-5699 | OTHER | UTN | None |
| 2011-003793-83 | EUDRACT_NUMBER | None | None |