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High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00242346
First received: October 18, 2005
Last updated: December 17, 2007
Last verified: December 2007
History of Changes

October 18, 2005
December 17, 2007
April 2003
Not Provided
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
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.
Complete list of historical versions of study NCT00242346 on ClinicalTrials.gov Archive Site
  • 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
  • a. To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance.
  • b. To determine the effects of high dose candesartan cilexetil on blood pressure
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Proteinuria
Drug: candesartan cilexetil
Not Provided
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. Epub 2009 Feb 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
December 2006
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00242346
D2452L00006, DC-AHS-0006, SMART
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Kazi Borkowski, PhD AstraZeneca
Principal Investigator: Norman MuirHead, MD London HSC
Principal Investigator: Ellen Burgess, MD Foothills Medical Center
AstraZeneca
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP