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

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: valsartan

Drug: irbesartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171080

CVAL489ADE19

Details and patient eligibility

About

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).

Enrollment

86 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.