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Completed

NCT Number: NCT00171080

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

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).

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Key information

Conditions

Hypertension Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

valsartan

Drug

Irbesartan

Drug

Primary outcomes

  1. Change from baseline in systolic blood pressure after 4 weeks

Secondary outcomes

  1. Change from baseline in diastolic blood pressure after 4 weeks

  2. Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure

  3. Adverse events and clinical laboratory abnormal results

  4. Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks

  5. Change from baseline in daytime and nighttime ambulatory blood pressures after 4 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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