Clinical trial NCT00362960: Olmesartan Medoxomil and Diabetic Nephropathy
Official title: Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Diabetic Nephropathy
Proteinuria
Renal Disease
Keywords: Type 2 Diabetes Mellitus
Diabetic Nephropathy
Inflammatory Markers
Proteinuria
Renal Disease
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Efficacy of olmesartan medoxomil doses compared to losartan in
measure: patients with type 2 diabetes and nephropathy in terms of the change in
measure: proteinuria (total urinary protein excretion) from baseline.
Secondary outcomes:
measure: Efficacy of the treatment with olmesartan medoxomil dosages compared to
measure: losartan in patients with type 2 diabetes and nephropathy in terms of
measure: change in:
measure: creatinine clearance (CLCR)
measure: the protein pattern (nephelometry)
measure: inflammatory markers (circulating serum markers).
measure: Evaluate safety and tolerability of all treatments.
Other outcomes:
Locations:
city: Frydlant v Cechach
country: Czech Republic
city: Liberec
country: Czech Republic
city: Prague
country: Czech Republic
city: Tartu
country: Estonia
city: Augsburg
country: Germany
city: Greifenstein-Beilstein
country: Germany
city: Hannover
country: Germany
city: Zwijndrecht
country: Netherlands
city: Grodzisk Mazowiecki
country: Poland
city: Krakow
country: Poland
city: Plock
country: Poland
city: Poznan
country: Poland
city: Pruszkow
country: Poland
city: Torun
country: Poland
city: Warsaw
country: Poland
city: Watlack
country: Poland
city: Wolomin
country: Poland
city: Wroclaw
country: Poland
city: Banska Bystrica
country: Slovakia
city: Kosice
country: Slovakia
city: Lucenec
country: Slovakia
city: Martin
country: Slovakia
city: Nitra
country: Slovakia
city: Nove Zamky
country: Slovakia
city: Sahy
country: Slovakia
city: Barcelona
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Hannover Medical School
name: H Haller, MD
role: PRINCIPAL_INVESTIGATOR
References: