High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Proteinuria

Treatments: Drug: candesartan cilexetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00242346

SMART

DC-AHS-0006

D2452L00006

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind