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Olmesartan Medoxomil and Diabetic Nephropathy

Primary Purpose

Type 2 Diabetes Mellitus, Diabetic Nephropathy, Proteinuria

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Olmesartan medoxomil
Losartan
Sponsored by
Sankyo Pharma Gmbh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Diabetic Nephropathy, Inflammatory Markers, Proteinuria, Renal Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Outcomes

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.

Full Information

First Posted
August 10, 2006
Last Updated
October 6, 2006
Sponsor
Sankyo Pharma Gmbh
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1. Study Identification

Unique Protocol Identification Number
NCT00362960
Brief Title
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

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sankyo Pharma Gmbh

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Diabetic Nephropathy, Proteinuria, Renal Disease
Keywords
Type 2 Diabetes Mellitus, Diabetic Nephropathy, Inflammatory Markers, Proteinuria, Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil
Intervention Type
Drug
Intervention Name(s)
Losartan
Primary Outcome Measure Information:
Title
Efficacy of olmesartan medoxomil doses compared to losartan in
Title
patients with type 2 diabetes and nephropathy in terms of the change in
Title
proteinuria (total urinary protein excretion) from baseline.
Secondary Outcome Measure Information:
Title
Efficacy of the treatment with olmesartan medoxomil dosages compared to
Title
losartan in patients with type 2 diabetes and nephropathy in terms of
Title
change in:
Title
creatinine clearance (CLCR)
Title
the protein pattern (nephelometry)
Title
inflammatory markers (circulating serum markers).
Title
Evaluate safety and tolerability of all treatments.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H Haller, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
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

12. IPD Sharing Statement

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Olmesartan Medoxomil and Diabetic Nephropathy

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