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

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug); irbesartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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).

Official title: 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 design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in systolic blood pressure after 4 weeks

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Investigative Centers, Germany

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: April 2004
Last updated: July 6, 2007