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High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

Primary Purpose

Proteinuria

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
candesartan cilexetil
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proteinuria focused on measuring Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
October 18, 2005
Last Updated
December 17, 2007
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00242346
Brief Title
High Doses of Candesartan Cilexetil on the Reduction of Proteinuria
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria
Keywords
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
270 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
candesartan cilexetil
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance
Title
To determine the effects of high dose candesartan cilexetil on blood pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazi Borkowski, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Norman MuirHead, MD
Organizational Affiliation
London HSC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen Burgess, MD
Organizational Affiliation
Foothills Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
St. John
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Courtice
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Richmond Hill
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Timmins
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Weston
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Ste-Foy
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19211712
Citation
Burgess 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.
Results Reference
derived

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High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

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