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

Novartis1 site in 1 country86 target enrollmentApril 2004

ConditionsHypertension

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 86
Locations: 1
Primary Endpoint: Change from baseline in systolic blood pressure after 4 weeks
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

March 2006

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility 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
•Atrial fibrillation
•Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Change from baseline in systolic blood pressure after 4 weeks

Secondary Outcomes

Adverse events and clinical laboratory abnormal results
Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure
Change from baseline in daytime and nighttime ambulatory blood pressures after 4 weeks
Change from baseline in diastolic blood pressure after 4 weeks
Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks