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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00171080

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: valsartan Drug: irbesartan	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Change from baseline in systolic blood pressure after 4 weeks []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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.