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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141453
First Posted: September 1, 2005
Last Update Posted: May 10, 2011
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 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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • Renal Composite Outcomes [ Time Frame: Randomization to 5 years ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

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
First Submitted: August 31, 2005
First Posted: September 1, 2005
Results First Submitted: August 31, 2009
Results First Posted: May 10, 2011
Last Update Posted: May 10, 2011
Last Verified: May 2011

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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Kidney Failure, Chronic
Diabetic Nephropathies
Proteinuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Diabetes Complications
Urination Disorders
Urological Manifestations
Signs and Symptoms
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action