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

May 9, 2011 updated by: Daiichi Sankyo Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

577

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Randomization to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 5 years
The Change in Proteinuria
Time Frame: Randomization to 5 years
The median percentage change from baseline value in urinary protein:creatinine ratio
Randomization to 5 years
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.
Randomization to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Co., Ltd.

Investigators

  • Study Director: Study Manager, R&D Division, Daiichi Sankyo Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (ESTIMATE)

September 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORIENT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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