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High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00242346
Recruitment Status : Completed
First Posted : October 20, 2005
Last Update Posted : December 19, 2007
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Proteinuria Drug: candesartan cilexetil Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : April 2003
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242346

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Canada, Alberta
Research Site
Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
Canada, British Columbia
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
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St. John, Newfoundland and Labrador, Canada
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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Courtice, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Oakville, Ontario, Canada
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Oshawa, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Scarborough, Ontario, Canada
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Sudbury, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Timmins, Ontario, Canada
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Toronto, Ontario, Canada
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Weston, Ontario, Canada
Canada, Quebec
Research Site
Greenfield Park, Quebec, Canada
Research Site
Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Quebec City, Quebec, Canada
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Ste-Foy, Quebec, Canada
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
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Study Director: Kazi Borkowski, PhD AstraZeneca
Principal Investigator: Norman MuirHead, MD London HSC
Principal Investigator: Ellen Burgess, MD Foothills Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00242346    
Other Study ID Numbers: D2452L00006
First Posted: October 20, 2005    Key Record Dates
Last Update Posted: December 19, 2007
Last Verified: December 2007
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
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Urination Disorders
Urologic Diseases
Urological Manifestations
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action