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

This study has been completed.

First Received: September 10, 2005 Last Updated: July 6, 2007 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171080

Purpose

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	Intervention	Phase
Hypertension	Drug: valsartan Drug: irbesartan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis High Blood Pressure Kidney Failure

Drug Information available for: Valsartan Irbesartan

U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment:	60
Study Start Date:	April 2004

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

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 1.
Atrial fibrillation

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171080

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CVAL489ADE19
Study First Received:	September 10, 2005
Last Updated:	July 6, 2007
ClinicalTrials.gov Identifier:	NCT00171080 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Hypertension
Valsartan
Dialysis
Renal Disease

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Irbesartan
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010