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Olmesartan Medoxomil and Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00362960
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : October 9, 2006
Information provided by:
Daiichi Sankyo, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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 2003
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Efficacy of olmesartan medoxomil doses compared to losartan in
  2. patients with type 2 diabetes and nephropathy in terms of the change in
  3. proteinuria (total urinary protein excretion) from baseline.

Secondary Outcome Measures :
  1. Efficacy of the treatment with olmesartan medoxomil dosages compared to
  2. losartan in patients with type 2 diabetes and nephropathy in terms of
  3. change in:
  4. creatinine clearance (CLCR)
  5. the protein pattern (nephelometry)
  6. inflammatory markers (circulating serum markers).
  7. Evaluate safety and tolerability of all treatments.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00362960

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Czech Republic
Frydlant v Cechach, Czech Republic
Liberec, Czech Republic
Prague, Czech Republic
Tartu, Estonia
Augsburg, Germany
Greifenstein-Beilstein, Germany
Hannover, Germany
Zwijndrecht, Netherlands
Grodzisk Mazowiecki, Poland
Krakow, Poland
Plock, Poland
Poznan, Poland
Pruszkow, Poland
Torun, Poland
Warsaw, Poland
Watlack, Poland
Wolomin, Poland
Wroclaw, Poland
Banska Bystrica, Slovakia
Kosice, Slovakia
Lucenec, Slovakia
Martin, Slovakia
Nitra, Slovakia
Nove Zamky, Slovakia
Sahy, Slovakia
Barcelona, Spain
Madrid, Spain
Sponsors and Collaborators
Sankyo Pharma Gmbh
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Principal Investigator: H Haller, MD Hannover Medical School

Layout table for additonal information Identifier: NCT00362960    
Other Study ID Numbers: SE-866/29
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: October 9, 2006
Last Verified: August 2006
Keywords provided by Daiichi Sankyo, Inc.:
Type 2 Diabetes Mellitus
Diabetic Nephropathy
Inflammatory Markers
Renal Disease
Additional relevant MeSH terms:
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Olmesartan Medoxomil
Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Urination Disorders
Urological Manifestations
Signs and Symptoms
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action