Olmesartan Medoxomil and Diabetic Nephropathy

Sponsor

Sankyo Pharma Gmbh (Industry)

Overall Status

Completed

CT.gov ID

NCT00362960

Collaborator

(none)

300

Enrollment

Locations

16.1

Duration (Months)

11.1

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Diabetic Nephropathy Proteinuria Renal Disease	Drug: Olmesartan medoxomil Drug: Losartan	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

May 1, 2003

Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Efficacy of olmesartan medoxomil doses compared to losartan in []
patients with type 2 diabetes and nephropathy in terms of the change in []
proteinuria (total urinary protein excretion) from baseline. []

Secondary Outcome Measures

Efficacy of the treatment with olmesartan medoxomil dosages compared to []
losartan in patients with type 2 diabetes and nephropathy in terms of []
change in: []
creatinine clearance (CLCR) []
the protein pattern (nephelometry) []
inflammatory markers (circulating serum markers). []
Evaluate safety and tolerability of all treatments. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	City	Country
1	Frydlant v Cechach	Czech Republic
2	Liberec	Czech Republic
3	Prague	Czech Republic
4	Tartu	Estonia
5	Augsburg	Germany
6	Greifenstein-Beilstein	Germany
7	Hannover	Germany
8	Zwijndrecht	Netherlands
9	Grodzisk Mazowiecki	Poland
10	Krakow	Poland
11	Plock	Poland
12	Poznan	Poland
13	Pruszkow	Poland
14	Torun	Poland
15	Warsaw	Poland
16	Watlack	Poland
17	Wolomin	Poland
18	Wroclaw	Poland
19	Banska Bystrica	Slovakia
20	Kosice	Slovakia
21	Lucenec	Slovakia
22	Martin	Slovakia
23	Nitra	Slovakia
24	Nove Zamky	Slovakia
25	Sahy	Slovakia
26	Barcelona	Spain
27	Madrid	Spain