High Doses of Candesartan Cilexetil on the Reduction of Proteinuria
December 17, 2007 updated by: AstraZeneca
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
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.
Study Overview
Study Type
Interventional
Enrollment
270
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada
- Research Site
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Edmonton, Alberta, Canada
- Research Site
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British Columbia
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
- Research Site
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Newfoundland and Labrador
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St. John, Newfoundland and Labrador, Canada
- Research Site
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Research Site
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Ontario
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Courtice, Ontario, Canada
- Research Site
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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
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Quebec
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Greenfield Park, Quebec, Canada
- Research Site
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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
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance
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To determine the effects of high dose candesartan cilexetil on blood pressure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kazi Borkowski, PhD, AstraZeneca
- Principal Investigator: Norman MuirHead, MD, London HSC
- Principal Investigator: Ellen Burgess, MD, Foothills Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
October 18, 2005
First Submitted That Met QC Criteria
October 18, 2005
First Posted (Estimate)
October 20, 2005
Study Record Updates
Last Update Posted (Estimate)
December 19, 2007
Last Update Submitted That Met QC Criteria
December 17, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2452L00006
- SMART
- DC-AHS-0006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.