VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis
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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).
A 2 x 5-week Multicenter, Cross-over Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan 80 mg Compared to Irbesartan 150 mg in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Patients with mild and moderate hypertension defined by a MSSBP ≥ 140 mmHG and < 180 mmHG at Visits 1 and 2 for treated and untreated patients
Chronic hemodialysis for at least 6 months prior to Visit 1 as substitution therapy.
If treated with epoetin: patients with a stable hematocrit ≤ 40% (± 5%).
Inability to discontinue angiotensin II receptor blockers (ARBs) safely for a period of 1 week, as required by the protocol.
Treatment with more than 3 different compounds for the treatment of hypertension at Visit 1.
Other protocol-defined exclusion criteria may apply.