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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

577 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Olmesartan Medoxomil and Diabetic Nephropathy

NCT00362960

Type 2 Diabetes Mellitus Diabetic Nephropathy Proteinuria +1 more

COMPLETED PHASE3

Olmesartan Medoxomil in Diabetes Mellitus

NCT00185159

Diabetes Mellitus, Type 2 Cardiovascular Disease Kidney Disease

COMPLETED PHASE3

A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)

NCT01698775

Type 2 Diabetes Mellitus

COMPLETED PHASE3

A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function (MK-3102-009)

NCT01407276

Chronic Renal Insufficiency Type 2 Diabetes Mellitus

COMPLETED PHASE1

OPTIMISE-CKD Drug Utilization

NCT05932901

Chronic Kidney Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Nephropathy Type 2 Diabetes Mellitus Proteinuria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Olmesartan medoxomil tablets 10mg to 40 mg

Group Type EXPERIMENTAL

olmesartan medoxomil

Intervention Type DRUG

Tablets 10, 20, or 40 mg

2

Matching placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo Tablets

Intervention Type DRUG

Matching placebo tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

olmesartan medoxomil

Tablets 10, 20, or 40 mg

Intervention Type DRUG

Placebo Tablets

Matching placebo tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No