low grade albuminuria MedDRA version: 9.1 Level: LLT Classification code 10001580 Term: Albuminuria
Conditions
Interventions
Trade Name: Aprovel
Pharmaceutical Form: Capsule*
INN or Proposed INN: Irbesartan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the pl
Sponsors
University Hospital of Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Albumin excretion > 3,9 mg/g creatinine in men and > 7,5 mg/g creatinine in women confirmed on two occasions. Age >=18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Antihypertensive treatment or blood pressure >= 140/90 mmHg • Antidiabetic treatment or blood glucose = 126 mg/dl • Blood pressure <120/80 mmHg • Treatment with lipid lowering drugs • Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. • Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study. • Treatment with any investigational product in the last 3 months before study entry • Pregnancy • Breast-feeding • Childbearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) • History of hypersensitivity to the investigational products or to drugs with similar chemical structures • Treatment with other ARBs in the last 4 weeks before study entry • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult • History of drug or alcohol abuse • Impaired hepatic function, as shown by transaminases higher than the double of the upper normal limit • Impaired renal function, as shown by estimated GFR (abbreviated MDRD formula) <60 ml/min • any renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is urinary albumin excretion measured as albumin to creatinine ratio from spot urine.;Secondary Objective: The secondary objectives of the study are 24 hour albumin excretion, 24-h ambulatory blood pressure, oral glucose tolerance test, adiponectin, HOMA index, lipid profile, CRP.;Primary end point(s): urinary albumin excretion measured as albumin to creatinine ratio from spot urine | — |
Countries
Germany
Outcome results
None listed