Olmesartan Medoxomil and Diabetic Nephropathy

NCT00362960 | Completed Phase 3

• 1 other identifier: SE-866/29
• Study Type: interventional
• Target: 300
• Locations: 6 countries
• Sites: 26

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus; Diabetic Nephropathy; Proteinuria; Renal Disease

Keywords

Type 2 Diabetes Mellitus; Diabetic Nephropathy; Inflammatory Markers; Proteinuria; Renal Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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)

Interventions

Olmesartan medoxomil DRUG

Losartan DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sankyo Pharma Gmbh: lead

Study Sites (27)

Unknown Facility

Frýdlant, Czechia

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Liberec, Czechia

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Prague, Czechia

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Tartu, Estonia

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Augsburg, Germany

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Greifenstein-Beilstein, Germany

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Hanover, Germany

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Zwijndrecht, Netherlands

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Grodzisk Mazowiecki, Poland

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Krakow, Poland

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Poznan, Poland

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Pruszków, Poland

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Płock, Poland

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Torun, Poland

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Warsaw, Poland

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Watlack, Poland

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Wołomin, Poland

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Wroclaw, Poland

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Banská Bystrica, Slovakia

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Košice, Slovakia

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Lučenec, Slovakia

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Martin, Slovakia

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Nitra, Slovakia

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Nové Zámky, Slovakia

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Šahy, Slovakia

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Barcelona, Spain

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Madrid, Spain

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies; Proteinuria; Kidney Diseases

Interventions

Olmesartan Medoxomil; Losartan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• H Haller, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: May 1, 2003
• Study Completion: September 1, 2004
• Last Updated: October 9, 2006

Record last verified: 2006-08

Locations

ES (2); PL (10); SL (7); NL (1); CZ (3); DE (3)