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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: candesartan cilexetil

Primary 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 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Kazi Borkowski, PhD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00242346

Study ID Number: D2452L00006

ClinicalTrials.gov Identifier: NCT00242346

Health Authority: Canada: Health Canada