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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

August 31, 2005
May 9, 2011
April 2003
August 2008   (final data collection date for primary outcome measure)
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
  • 2. Safety
  • 1.First occurrence of any of the folllwing events:
  • Doubling of serum creatinine level
  • End stage renal disease
  • Death
Complete list of historical versions of study NCT00141453 on ClinicalTrials.gov Archive Site
  • 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.
  • 1. First occurrence of any of the following:
  • Cardiovascular death
  • non-fatal stroke
  • non-fatal myocardial infarction
  • hospitalization for unstable angina
  • hospitalization for heart failure
  • coronary/carotid/periperal revascularization
  • lower extremity amputation
  • 2. change in proteinuria
  • 3. reciprocal of serum creatinine
Not Provided
Not Provided
 
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
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

The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetic Nephropathy
  • Type 2 Diabetes Mellitus
  • Proteinuria
  • Drug: olmesartan medoxomil
    Tablets 10, 20, or 40 mg
  • Drug: Placebo Tablets
    Matching placebo tablets
  • Experimental: 1
    Olmesartan medoxomil tablets 10mg to 40 mg
    Intervention: Drug: olmesartan medoxomil
  • Placebo Comparator: 2
    Matching placebo tablets
    Intervention: Drug: Placebo Tablets
Imai E, Chan JC, Ito S, Yamasaki T, Kobayashi F, Haneda M, Makino H; ORIENT study investigators. Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study. Diabetologia. 2011 Dec;54(12):2978-86. Epub 2011 Oct 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
577
January 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Japan
 
NCT00141453
ORIENT
Not Provided
Shuji Tsukiyama, Daiichi Sankyo Co., Ltd. Tokyo, Japan
Daiichi Sankyo Co., Ltd.
Not Provided
Study Director: Study Manager R&D Division, Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP