High Doses of Candesartan Cilexetil on the Reduction of Proteinuria - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00242346

Purpose

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	Intervention	Phase
Proteinuria	Drug: candesartan cilexetil	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Urine and Urination

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

Estimated Enrollment:	270
Study Start Date:	April 2003
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242346

Locations

Canada, Alberta
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Canada, British Columbia
Research Site
Kelowna, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
Research Site
St. John, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Courtice, Ontario, Canada
Research Site
Kitchener, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Oakville, Ontario, Canada
Research Site
Oshawa, Ontario, Canada
Research Site
Richmond Hill, Ontario, Canada
Research Site
Scarborough, Ontario, Canada
Research Site
Sudbury, Ontario, Canada
Research Site
Thunder Bay, Ontario, Canada
Research Site
Timmins, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Weston, Ontario, Canada
Canada, Quebec
Research Site
Greenfield Park, Quebec, Canada
Research Site
Laval, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Quebec City, Quebec, Canada
Research Site
Ste-Foy, Quebec, Canada
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Kazi Borkowski, PhD	AstraZeneca
Principal Investigator:	Norman MuirHead, MD	London HSC
Principal Investigator:	Ellen Burgess, MD	Foothills Medical Center

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00242346 History of Changes
Other Study ID Numbers:	D2452L00006, DC-AHS-0006, SMART
Study First Received:	October 18, 2005
Last Updated:	December 17, 2007
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Hypertension

Additional relevant MeSH terms:

Hypertension
Proteinuria
Vascular Diseases
Cardiovascular Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Candesartan cilexetil

Candesartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012