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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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valsartan

Intervention Type DRUG

irbesartan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No