Olmesartan Medoxomil and Diabetic Nephropathy

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362960
• Other study ID #: SE-866/29
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2006
• Last updated: October 6, 2006
• Start date: May 2003
• Est. completion date: September 2004

Study information

• Verified date: August 2006
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 ?-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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Proteinuria
• Renal Disease
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Olmesartan medoxomil

• Losartan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sankyo Pharma Gmbh

Countries where clinical trial is conducted

Czech Republic,  Estonia,  Germany,  Netherlands,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of olmesartan medoxomil doses compared to losartan in
Primary	patients with type 2 diabetes and nephropathy in terms of the change in
Primary	proteinuria (total urinary protein excretion) from baseline.
Secondary	Efficacy of the treatment with olmesartan medoxomil dosages compared to
Secondary	losartan in patients with type 2 diabetes and nephropathy in terms of
Secondary	change in:
Secondary	creatinine clearance (CLCR)
Secondary	the protein pattern (nephelometry)
Secondary	inflammatory markers (circulating serum markers).
Secondary	Evaluate safety and tolerability of all treatments.