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This study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. Patients remain on their prior CHF standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan 160 mg | Drug | |||
| valsartan 160 mg BID | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure |
| Measure | Description | Time Frame |
|---|---|---|
| Patients reaching target dose at 10 weeks | ||
| Change from baseline in systolic blood pressure at each study visit | ||
| Change from baseline in diastolic blood pressure at each study visit |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20730060 | Derived | Anand IS, Deswal A, Kereiakes DJ, Purkayastha D, Zappe DH. Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure. Vasc Health Risk Manag. 2010 Aug 9;6:449-55. |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Change from baseline in blood potassium at each study visit |
| Change from baseline in blood creatinine at each study visit |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |