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Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914524
First Posted: June 5, 2009
Last Update Posted: September 29, 2010
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.
Information provided by:
Daiichi Sankyo, Inc.
  Purpose
The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg, 20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of treatment. The secondary endpoint was creatinine clearance (Ccr).

Condition Intervention Phase
Chronic Glomerulonephritis Diabetic Nephropathy Drug: olmesartan medoxomil Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of Olmesartan Medoxomil (CS-866) in Normotensive Patients With Chronic Glomerulonephritis or Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • The change in the urinary protein/creatinine ratio from baseline to the end of treatment. [ Time Frame: baseline to 16 weeks ]

Secondary Outcome Measures:
  • The change of creatinine clearance [ Time Frame: baseline to 16 weeks ]

Enrollment: 49
Study Start Date: January 2005
Study Completion Date: October 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
16 weeks of treatment starting with 5 mg of olmesartan medoxomil. If tolerated, the dose was increased to the next higher dose at weeks 4, 8, and 12.
Drug: olmesartan medoxomil
olmesartan medoxomil tablets, once daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • urinary protein/creatinine ratio in the 0.50 g/g to 3.50 g/g creatinine range
  • normal sitting blood pressure values: systolic blood pressure of 100 mmHg or above but below 140 mmHg; diastolic blood pressure of 50 mmHg or above but less than 90 mmHg

Exclusion Criteria:

  • treatment with corticosteroids or immunosuppressants
  • treatment with antihypertensives (other than ARBs and ACE inhibitors)
  • serum potassium level of 5.5 mEq/l or above
  • serum creatinine level of 2.0 mg/dl or above
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00914524


Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
  More Information

Responsible Party: Yasuhiro Tomono, Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT00914524     History of Changes
Other Study ID Numbers: CS0866-C-J201
First Submitted: June 3, 2009
First Posted: June 5, 2009
Last Update Posted: September 29, 2010
Last Verified: September 2010

Keywords provided by Daiichi Sankyo, Inc.:
Chronic Glomerulonephritis
Diabetic Nephropathy
Angiotensin II Receptor Blocker
Urinary Protein

Additional relevant MeSH terms:
Glomerulonephritis
Kidney Diseases
Diabetic Nephropathies
Chronic Disease
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nephritis
Disease Attributes
Pathologic Processes
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action