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Completed

NCT Number: NCT00242346

High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria.

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Key information

Conditions

Proteinuria Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent
  • Stable hypertension defined as no new antihypertensive medication started within 6 weeks of Visit 1
  • Minimum 6-month history of hypertension and primary glomerular disease
  • Hypertensive nephrosclerosis
  • Diabetic nephropathy with stable proteinuria as defined by ≥ 1g/24 hours on more than one occasion within 6 months prior to Visit 1

Exclusion criteria

  • Persistent hypertension
  • New anti-hypertensive medications started within 6 weeks of Visit 1
  • Significant cardiac disease or Liver disease
  • Females of childbearing potential without reliable contraception
  • Pregnant women and women who are breast-feeding

Treatment and study plan

Candesartan cilexetil

Drug

Primary outcomes

  1. To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection

Secondary outcomes

  1. To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance

  2. To determine the effects of high dose candesartan cilexetil on blood pressure

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Double-Blind, Randomised, Dose Ranging, Multi-Centre, Phase IIIb Study to Evaluate the Efficacy and Safety of High Doses of Candesartan Cilexetil (Atacand®) on the Reduction of Proteinuria in the Treatment of Subjects With Hypertension and Moderate to Severe Proteinuria

Important dates

Study start
2003
Study completion
2006
First posted
Oct 20, 2005
Registry last updated
Dec 19, 2007

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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