High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

Condition(s) targeted: Proteinuria

Intervention: candesartan cilexetil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Kazi Borkowski, PhD, Study Director, Affiliation: AstraZeneca
Norman MuirHead, MD, Principal Investigator, Affiliation: London HSC
Ellen Burgess, MD, Principal Investigator, Affiliation: Foothills Medical Center

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.

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 design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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:

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Research Site, Calgary, Alberta, Canada

Research Site, Edmonton, Alberta, Canada

Research Site, Kelowna, British Columbia, Canada

Research Site, Vancouver, British Columbia, Canada

Research Site, Winnipeg, Manitoba, Canada

Research Site, St. John, Newfoundland and Labrador, Canada

Research Site, Halifax, Nova Scotia, Canada

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

Research Site, Greenfield Park, Quebec, Canada

Research Site, Laval, Quebec, Canada

Research Site, Montreal, Quebec, Canada

Research Site, Ste-Foy, Quebec, Canada

Research Site, Quebec City, Quebec, Canada

Research Site, Saskatoon, Saskatchewan, Canada

Starting date: April 2003
Ending date: December 2006
Last updated: December 17, 2007