CompletedPhase 3

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

Germany, Switzerland86 participantsStarted 2004-04

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change from baseline in systolic blood pressure after 4 weeks

Trial details

NCT IDNCT00171080

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-03

View on ClinicalTrials.gov More Hypertension trials