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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00914524
First received: June 3, 2009
Last updated: September 28, 2010
Last verified: September 2010
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of creatinine clearance [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914524

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

No publications provided

Responsible Party: Yasuhiro Tomono, Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT00914524     History of Changes
Other Study ID Numbers: CS0866-C-J201
Study First Received: June 3, 2009
Last Updated: September 28, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on April 20, 2014