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ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00141453
First received: August 31, 2005
Last updated: May 9, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.


Condition Intervention Phase
Diabetic Nephropathy
Type 2 Diabetes Mellitus
Proteinuria
 Drug: olmesartan medoxomil
Drug: Placebo Tablets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: CS-866DM Phase 3 Clinical Study: A Double-Blind Controlled Trial in Patients With Diabetic Nephropathy and Overt Proteinuria Secondary to Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Renal Composite Outcomes [ Time Frame: Randomization to 5 years ] [ Designated as safety issue: No ]
    first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease


Secondary Outcome Measures:
  • Number of Participants Experiencing Cardiovascular Composite Outcomes [ Time Frame: Within 5 years ] [ Designated as safety issue: No ]
    Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization.

  • The Change in Proteinuria [ Time Frame: Randomization to 5 years ] [ Designated as safety issue: No ]
    The median percentage change from baseline value in urinary protein:creatinine ratio

  • Reciprocal (1/Serum Creatinine) of Serum Creatinine [ Time Frame: Randomization to 5 years ] [ Designated as safety issue: No ]
    The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study.


Enrollment: 577
Study Start Date: April 2003
Study Completion Date: January 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Olmesartan medoxomil tablets 10mg to 40 mg
 Drug: olmesartan medoxomil
Tablets 10, 20, or 40 mg
Placebo Comparator: 2
Matching placebo tablets
 Drug: Placebo Tablets
Matching placebo tablets

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes
  • albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning urinalysis
  • serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men

Exclusion Criteria:

  • type 1 diabetes
  • non-diabetic nephropathy
  • history of myocardial infarction
  • history of cardiac bypass grafting within 3 months
  • history of percutaneous coronary intervention (PCI) within 6 months
  • history of carotid artery or peripheral artery revascularization within 6 months
  • stroke or transient ischemic attack (TIA) within 1 year
  • unstable angina pectoris
  • heart failure of NYHA functional classes III or IV
  • rapid progression of kidney disease within 3 months
  • severe orthostatic hypotension
  • serum potassium level =<3.5 mEq(mmol)/L or =>5.5 mEq(mmol)L
  • history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors
  • poor glycemic control: HbA1c level =>11%
  • history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141453

Locations
China
Hong Kong, China
Japan
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Study Director: Study Manager R&D Division, Daiichi Sankyo Co., Ltd.
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shuji Tsukiyama, Daiichi Sankyo Co., Ltd. Tokyo, Japan
ClinicalTrials.gov Identifier: NCT00141453     History of Changes
Other Study ID Numbers: ORIENT
Study First Received: August 31, 2005
Results First Received: August 31, 2009
Last Updated: May 9, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare
Hong Kong: Department of Health

Keywords provided by Daiichi Sankyo Inc.:
angiotensin II type I receptor blockers
diabetic nephropathy
end-stage renal disease
 renal failure
type 2 diabetes
olmesartan medoxomil

Additional relevant MeSH terms:
Olmesartan medoxomil
Olmesartan
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Kidney Failure, Chronic
Proteinuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
 Renal Insufficiency, Chronic
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013