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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171080
• Other study ID #: CVAL489ADE19
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2005
• Last updated: May 16, 2017
• Start date: April 2004
• Est. completion date: March 2006

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• valsartan

• irbesartan

Locations

Country	Name	City	State
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Leidig M, Bambauer R, Kirchertz EJ, Szabã T, Handrock R, Leinung D, Baier M, Schmieder RE. Efficacy, safety and tolerability of valsartan 80 mg compared to irbesartan 150 mg in hypertensive patients on long-term hemodialysis (VALID study). Clin Nephrol. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in systolic blood pressure after 4 weeks
Secondary	Change from baseline in diastolic blood pressure after 4 weeks
Secondary	Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure
Secondary	Adverse events and clinical laboratory abnormal results
Secondary	Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks
Secondary	Change from baseline in daytime and nighttime ambulatory blood pressures after 4 weeks

External Links

•   Results for CVAL489ADE19 from the Novartis Clinical Trials website