Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00171080
Start Date
April 1 2004
End Date
March 1 2006
Last Update
May 18 2017
Active Locations (2)
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1
Investigative Centers, Germany
2
Novartis Pharmaceuticals
Basel, Switzerland