ow grade albuminuria: reaching a new target for irbesarta

Active, not recruiting

• Conditions: low grade albuminuria; MedDRA version: 9.1Level: LLTClassification code 10001580Term: Albuminuria

• Registration Number: EUCTR2007-000501-29-DE
• Lead Sponsor: niversity Hospital of Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-30
• Last Update Posted: 29 July 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 40

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 <=75 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified