Olmesartan Medoxomil and Diabetic Nephropathy

October 6, 2006 updated by: Sankyo Pharma Gmbh

Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sankyo Pharma Gmbh

Investigators

  • Principal Investigator: H Haller, MD, Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 11, 2006

First Posted (ESTIMATE)

August 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2006

Last Update Submitted That Met QC Criteria

October 6, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE-866/29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Losartan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe