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.

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