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This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| valsartan HCTZ | Experimental |
| |
| HCTZ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan/Hydrochlorothiazide | Drug | 160/12.5 mg taken once daily orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks | ||
| Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in systolic blood pressure after 2 weeks and 4 weeks | ||
| Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks | ||
| Change in systolic blood pressure at 20 weeks compared to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis 862-778-8300 Pharmaceuticals | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this study. | View source |
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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 |
| D014867 | Water |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| HCTZ | Drug | 25 mg taken once daily orally |
|
|
| Change in diastolic blood pressure at 20 weeks compared to 4 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 |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |