High Doses of Candesartan Cilexetil on the Reduction of Proteinuria
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
3 other identifiers
interventional
270
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2003
Typical duration for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedDecember 19, 2007
December 1, 2007
October 18, 2005
December 17, 2007
Conditions
Keywords
Outcome Measures
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 (2)
To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance
To determine the effects of high dose candesartan cilexetil on blood pressure
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (26)
Research Site
Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Courtice, Ontario, Canada
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Greater Sudbury, 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 Village, 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
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
Related Publications (3)
Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
PMID: 38682786DERIVEDCooper TE, Teng C, Tunnicliffe DJ, Cashmore BA, Strippoli GF. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers for adults with early (stage 1 to 3) non-diabetic chronic kidney disease. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD007751. doi: 10.1002/14651858.CD007751.pub3.
PMID: 37466151DERIVEDBurgess E, Muirhead N, Rene de Cotret P, Chiu A, Pichette V, Tobe S; SMART (Supra Maximal Atacand Renal Trial) Investigators. Supramaximal dose of candesartan in proteinuric renal disease. J Am Soc Nephrol. 2009 Apr;20(4):893-900. doi: 10.1681/ASN.2008040416. Epub 2009 Feb 11.
PMID: 19211712DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kazi Borkowski, PhD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Norman MuirHead, MD
London HSC
- PRINCIPAL INVESTIGATOR
Ellen Burgess, MD
Foothills Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 20, 2005
Study Start
April 1, 2003
Study Completion
December 1, 2006
Last Updated
December 19, 2007
Record last verified: 2007-12