| Trial ID: | L1134 |
| Source ID: | NCT01447485
|
| Associated Drug: |
Valsartan (Val489)
|
| Title: |
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Chronic Kidney Disease|Nephrotic Syndrome
|
| Interventions: |
DRUG: Valsartan (VAL489)
|
| Outcome Measures: |
Primary: AUC of valsartan in plasma, Up to 24 hours post-dose|Cmax of valsartan in plasma, Up to 24 hours post-dose|Tmax of valsartan in plasma, Up to 24 hours post-dose|T1/2 of valsartan in plasma, Up to 24 hours post-dose|CL/F of valsartan in plasma, Up to 24 hours post-dose | Secondary: ECG evaluations, 24 hours post-dose|Standard clinical laboratory evaluations, 24 hours post-dose|Vital signs, 2, 4, and 24 hours post-dose|Physical examination, 24 hours post-dose|Number and severity of adverse events, Up to 24 hours post-dose
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE1
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2011-08
|
| Completion Date: |
2011-10
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-21
|
| Locations: |
Novartis Investigative Site, Aichi, Japan|Novartis Investigative Site, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01447485
|
