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Trial record 51 of 135 for:    OLMESARTAN

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.
 
ClinicalTrials.gov Identifier: NCT00362960
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : October 9, 2006
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE August 10, 2006
First Posted Date  ICMJE August 15, 2006
Last Update Posted Date October 9, 2006
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2006)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00362960 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2006)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olmesartan Medoxomil and Diabetic Nephropathy
Official Title  ICMJE Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy
Brief Summary Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Diabetic Nephropathy
  • Proteinuria
  • Renal Disease
Intervention  ICMJE
  • Drug: Olmesartan medoxomil
  • Drug: Losartan
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 11, 2006)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Estonia,   Germany,   Netherlands,   Poland,   Slovakia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00362960
Other Study ID Numbers  ICMJE SE-866/29
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Sankyo Pharma Gmbh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: H Haller, MD Hannover Medical School
PRS Account Daiichi Sankyo, Inc.
Verification Date August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP