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

Novartis86 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

valsartanDRUG

irbesartanDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Investigative Centers, Germany

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Change from baseline in systolic blood pressure after 4 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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