High Doses of Candesartan Cilexetil on the Reduction of Proteinuria
Phase 3
Completed
- Conditions
- Proteinuria
- Registration Number
- NCT00242346
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇨🇦Saskatoon, Saskatchewan, Canada