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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171080

Enrollment

Registered

2005-09-15

Start date

2004-04-30

Completion date

2006-03-31

Last updated

2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Valsartan, Dialysis, Renal Disease

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-term haemodialysis with mild to moderate increased mean supine systolic blood pressure (MSSBP).

Interventions

DRUGvalsartan

DRUGirbesartan

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in systolic blood pressure after 4 weeks	—

Secondary

Measure	Time frame
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	—

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026