High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

Proteinuria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242346
• Other study ID #: D2452L00006
• Secondary ID: DC-AHS-0006SMART
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2005
• Last updated: December 17, 2007
• Start date: April 2003
• Est. completion date: December 2006

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Proteinuria

Intervention

Drug:
• candesartan cilexetil

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance
Secondary	To determine the effects of high dose candesartan cilexetil on blood pressure