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Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sitting systolic blood pressure after 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks | ||
| Change from baseline systolic blood pressure after 4 weeks | ||
| Change from baseline diastolic blood pressure after 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria will also apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | E.Hanover | New Jersey | 07936 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21545397 | Result | Wells T, Blumer J, Meyers KE, Neto JP, Meneses R, Litwin M, Vande Walle J, Solar-Yohay S, Shi V, Han G; Valsartan Pediatric Hypertension Study Group. Effectiveness and safety of valsartan in children aged 6 to 16 years with hypertension. J Clin Hypertens (Greenwich). 2011 May;13(5):357-65. doi: 10.1111/j.1751-7176.2011.00432.x. Epub 2011 Mar 18. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Change in diastolic blood pressure after 2 weeks to 4 weeks |
| Change from baseline diastolic blood pressure after 4 weeks |
| Investigative Centers |
| Germany |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |