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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003793-83 | EudraCT Number | ||
| U1111-1123-5699 | Other Identifier | UTN |
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Primary Objective:
Secondary Objectives:
The total duration for this study will be around 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo |
|
| Cohort 2 | Experimental | Dose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR407899A | Drug | Pharmaceutical form:capsule Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients reporting Adverse Events (AEs) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical safety laboratory measurement including hematology and biochemistry | 8 weeks | |
| urine and blood renal function markers | 8 weeks | |
| ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure) |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 498002 | Chisinau | 2025 | Moldova | |||
| Investigational Site Number 642001 |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 8 weeks |
| AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro) | 8 weeks |
| AUC | 8 weeks |
| Cmax | 8 weeks |
| t1/2z | 8 weeks |
| 24-hr ambulatory blood pressure | Day-1, Day 14 and Day 19 |
| Bucharest |
| Romania |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |