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

ClinicalTrials.gov processed this record on September 18, 2014