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The purpose of the study is to compare the efficacy, safety and tolerability of valsartan 80 mg (with a starting dose of 40 mg) to irbesartan 150 mg (with a starting dose of 75 mg) in patients on long-term haemodialysis with mild to moderate increased mean supine systolic blood pressure (MSSBP).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug | |||
| irbesartan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in systolic blood pressure after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in diastolic blood pressure after 4 weeks | ||
| Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure | ||
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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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Centers | Germany | |||||
| Novartis Pharmaceuticals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18538118 | Result | Leidig M, Bambauer R, Kirchertz EJ, Szaba T, Handrock R, Leinung D, Baier M, Schmieder RE. Efficacy, safety and tolerability of valsartan 80 mg compared to irbesartan 150 mg in hypertensive patients on long-term hemodialysis (VALID study). Clin Nephrol. 2008 Jun;69(6):425-32. doi: 10.5414/cnp69425. |
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| Adverse events and clinical laboratory abnormal results |
| Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks |
| Change from baseline in daytime and nighttime ambulatory blood pressures after 4 weeks |
| Basel |
| Switzerland |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D011083 | Polycyclic Compounds |
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