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The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan + amlodipine | Drug | |||
| Valsartan + HCTZ | Drug | |||
| Amlodipine + HCTZ | Drug | |||
| Valsartan + amlodipine + HCTZ | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline diastolic blood pressure after 8 weeks | ||
| Change from baseline systolic blood pressure after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure less than 140/90 mmHg after 8 weeks | ||
| Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks | ||
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | East Hanover | New Jersey | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23721363 | Derived | Calhoun DA, Lacourciere Y, Crikelair N, Jia Y, Glazer RD. Effects of demographics on the antihypertensive efficacy of triple therapy with amlodipine, valsartan, and hydrochlorothiazide for moderate to severe hypertension. Curr Med Res Opin. 2013 Aug;29(8):901-10. doi: 10.1185/03007995.2013.803057. Epub 2013 Jul 1. | |
| 21248785 | Derived |
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| Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks |
| Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements |
| Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks |
| Lacourciere Y, Crikelair N, Glazer RD, Yen J, Calhoun DA. 24-Hour ambulatory blood pressure control with triple-therapy amlodipine, valsartan and hydrochlorothiazide in patients with moderate to severe hypertension. J Hum Hypertens. 2011 Oct;25(10):615-22. doi: 10.1038/jhh.2010.115. Epub 2011 Jan 20. |
| 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 |
| D006852 | Hydrochlorothiazide |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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