Olmesartan Medoxomil and Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00362960
First received: August 10, 2006
Last updated: October 6, 2006
Last verified: August 2006
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

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.

Estimated Enrollment: 300
Study Start Date: May 2003
Estimated Study Completion Date: September 2004
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362960

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

No publications provided

ClinicalTrials.gov Identifier: NCT00362960     History of Changes
Other Study ID Numbers: SE-866/29
Study First Received: August 10, 2006
Last Updated: October 6, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Daiichi Sankyo Inc.:
Type 2 Diabetes Mellitus
Diabetic Nephropathy
Inflammatory Markers
Proteinuria
Renal Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Proteinuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Urination Disorders
Urological Manifestations
Signs and Symptoms
Losartan
Olmesartan medoxomil
Olmesartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014