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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
Results First Received: August 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Diabetic Nephropathy
Type 2 Diabetes Mellitus
Proteinuria
Interventions: Drug: olmesartan medoxomil
Drug: Placebo Tablets

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study population was defined by the inclusion criteria. This study was carried out at 74 centers in Japan and 3 centers in Hong Kong. After the screening visit, the patients that met inclusion and exclusion criteria were selected to participate in the study. First Patient in: 19 May 2003.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During 6-week screening, patients were treated with placebo and assessed for eligibility. Eligible patients were assigned to 10mg of olmesartan or placebo. 857 were screened; 577 were randomized; 566=the full analysis set (11 who completed were excluded for protocol violations). Data are based on the participants in the full analysis set.

Reporting Groups
  Description
Olmesartan Medoxomil Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
Placebo Comparator Matching placebo tablets

Participant Flow:   Overall Study
    Olmesartan Medoxomil     Placebo Comparator  
STARTED     288     289  
COMPLETED     282     284  
NOT COMPLETED     6     5  
Protocol Violation                 6                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Olmesartan Medoxomil Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
Placebo Comparator Matching placebo tablets
Total Total of all reporting groups

Baseline Measures
    Olmesartan Medoxomil     Placebo Comparator     Total  
Number of Participants  
[units: participants]
 		  282     284     566  
Age  
[units: years]
Mean ± Standard Deviation 		  59.1  ± 8.1     59.2  ± 8.1     59.2  ± 8.1  
Gender  
[units: participants]
 		     
Female     83     92     175  
Male     199     192     391  
Region of Enrollment  
[units: participants]
 		     
East Asia     282     284     566  
Use of ACE inhibitors  
[units: participants]
 		     
Used ACE Inhibitors     205     209     414  
Did not use ACE Inhibitors     77     75     152  
Diastolic blood pressure  
[units: mmHg]
Mean ± Standard Deviation 		  77.8  ± 10.4     77.2  ± 10.6     77.5  ± 10.5  
HbA1c  
[units: Percentage of HbA1c]
Mean ± Standard Deviation 		  7.11  ± 1.20     7.05  ± 1.24     7.08  ± 1.22  
Serum creatinine  
[units: mg/dL]
Mean ± Standard Deviation 		  1.62  ± 0.32     1.62  ± 0.35     1.62  ± 0.34  
Systolic Blood Pressure  
[units: mmHg]
Mean ± Standard Deviation 		  141.7  ± 17.0     140.8  ± 18.0     141.3  ± 17.5  
Urinary albumin:creatinine ratio  
[units: g/g]
Median ( Inter-Quartile Range ) 		  1.70  
  ( 0.77 to 3.00 )   		  1.69  
  ( 0.87 to 3.12 )   		  1.69  
  ( 0.82 to 3.03 )  
Urinary protein: creatinine ratio  
[units: g/g]
Median ( Inter-Quartile Range ) 		  2.19  
  ( 0.99 to 3.87 )   		  2.05  
  ( 1.10 to 3.80 )   		  2.12  
  ( 1.03 to 3.82 )  



  Outcome Measures
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1.  Primary:   Renal Composite Outcomes   [ Time Frame: Randomization to 5 years ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants Experiencing Cardiovascular Composite Outcomes   [ Time Frame: Within 5 years ]
  Show Outcome Measure 2

3.  Secondary:   The Change in Proteinuria   [ Time Frame: Randomization to 5 years ]
  Show Outcome Measure 3

4.  Secondary:   Reciprocal (1/Serum Creatinine) of Serum Creatinine   [ Time Frame: Randomization to 5 years ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Howard Kessler
Organization: Daiichi Sankyo, Inc
phone: 732-590-5032
e-mail: hmkessler@dsi.com


No publications provided by Daiichi Sankyo Inc.

Publications automatically indexed to this study:


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