Proteinuria
Conditions
Keywords
Hypertension
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.
Interventions
DRUGcandesartan cilexetil
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed