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

NCT00171080 | Completed Phase 3

• 1 other identifier: CVAL489ADE19
• Study Type: interventional
• Target: 86
• Locations: 2 countries
• Sites: 2

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).

Conditions

Hypertension

Keywords

Hypertension; Valsartan; Dialysis; Renal Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in systolic blood pressure after 4 weeks

Secondary Outcomes (5)

• 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

Interventions

valsartan DRUG

irbesartan DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (1)

• Leidig M, Bambauer R, Kirchertz EJ, Szaba 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. 2008 Jun;69(6):425-32. doi: 10.5414/cnp69425.

  PMID: 18538118 RESULT

MeSH Terms

Conditions

Hypertension; Kidney Diseases

Interventions

Valsartan; Irbesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Polycyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

DE (1); CH (1)