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
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00171080
- Lead Sponsor
- Novartis
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
- 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%).
Exclusion Criteria
- 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.
- Atrial fibrillation
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change from baseline in systolic blood pressure after 4 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in diastolic blood pressure after 4 weeks Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks Adverse events and clinical laboratory abnormal results Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure Change from baseline in daytime and nighttime ambulatory blood pressures after 4 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇨🇭Basel, Switzerland