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This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug | |||
| hydrochlorothiazide | Drug | |||
| amlodipine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 8 weeks. | ||
| Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 4, 12, and 16 weeks. |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | Basel | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18326958 | Result | Allemann Y, Fraile B, Lambert M, Barbier M, Ferber P, Izzo JL Jr. Efficacy of the combination of amlodipine and valsartan in patients with hypertension uncontrolled with previous monotherapy: the Exforge in Failure after Single Therapy (EX-FAST) study. J Clin Hypertens (Greenwich). 2008 Mar;10(3):185-94. doi: 10.1111/j.1751-7176.2008.07516.x. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D006852 | Hydrochlorothiazide |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Change from baseline diastolic and systolic blood pressure measurements after 4, 8, 12, and 16 weeks |
| Diastolic blood pressure less than 90 mmHg in non-diabetic patients and diastolic blood pressure less than 80 mmHg in diabetic patients after 4, 8, 12, and 16 weeks |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| 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 |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |