Olmesartan Medoxomil and Diabetic Nephropathy

Daiichi Sankyo

Status and phase

Completed

Phase 3

Conditions

Diabetic Nephropathy

Proteinuria

Type 2 Diabetes Mellitus

Renal Disease

Treatments

Drug: Losartan

Drug: Olmesartan medoxomil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00362960

SE-866/29

Details and patient eligibility

About

Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female European out-patients
Greater than or equal to 30 years of age
Type 2 diabetes first diagnosed at greater than or equal to 30 years of age
Urinary protein excretion between 200-4000 mg/day exclusive
Mean sitting dBP less than or equal to 110 mgHg
Medically justifiable to withdraw antihypertensive treatment due to poor tolerability or inefficacy of previous treatment, or verification that treatment is still necessary

Exclusion criteria

Females pregnant, nursing or planning to become pregnant or were of childbearing potential and not using acceptable methods of contraception
Secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dBP exceeding 110 mmHg or sitting sBP exceeding 200 mmHg
ECG evidence of 2nd or 3rd degree AV-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia
Presence of significant cardiovascular disease
Significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease
Concurrent renal disease, nephrectomy and/or renal transplant, serum creatinine level greater than or equal to 2.0 mg/dL or creatinine clearance CLCR less than or equal to 50 mL/min
Clinically significant lab abnormalities (ASAT/SGOT, ALAT/SGPT and γ-GT )
Serum potassium level < 2.5 mmol/L or > 5.5 mmol/L
Treatment of concurrent indications with drugs or medication which could have influenced BP
History of hypersensitivity, lack of response or contraindication to Ang II-antagonists, HCTZ or atenolol, or hypersensitivity to related drugs (cross-allergy)