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This trial will compare valsartan and amlodipine combination therapies to valsartan and amlodipine monotherapy,and placebo for treating patients with hypertension
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan+amlodipine combination | Drug | |||
| valsartan | Drug | |||
| amlodipine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (endpoint-Week 8). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (endpoint-Wk 8) | ||
| Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(endpoint-Wk 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis pharmaceuticals | Sponsor GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States | ||
| Sites in Germany |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068838 | Amlodipine, Valsartan Drug Combination |
| D000068756 | Valsartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sitting and standing pulse |
| Germany |
| Germany |
| D004095 |
| Dihydropyridines |
| D011725 | Pyridines |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |