Trial · NCT00141453

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

NCT00141453, Phase 3, Completed, Daiichi Sankyo Co., Ltd.; results first posted 2011-05-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial. Trials, record NCT00141453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00141453

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
NCT number: NCT00141453
Status: Completed
Phases: Phase 3
Enrollment: 577 participants, actual
Lead sponsor: Daiichi Sankyo Co., Ltd.
Conditions: Diabetic Nephropathy, Type 2 Diabetes Mellitus, Proteinuria
Interventions: olmesartan medoxomil, Placebo Tablets
First posted: 2005-09-01
Last updated: 2011-05-10
Results first posted: 2011-05-10

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Renal Composite Outcomes	Randomization to 5 years	first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
Secondary	Number of Participants Experiencing Cardiovascular Composite Outcomes	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.
Secondary	The Change in Proteinuria	Randomization to 5 years	The median percentage change from baseline value in urinary protein:creatinine ratio
Secondary	Reciprocal (1/Serum Creatinine) of Serum Creatinine	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Renal Composite Outcomes	Randomization to 5 years	Full analysis set=566	participants	NUMBER
SECONDARY	Number of Participants Experiencing Cardiovascular Composite Outcomes	Within 5 years	Full analysis set=566	participants	NUMBER
SECONDARY	The Change in Proteinuria	Randomization to 5 years	Full analysis set=566	Median percentage change in ratio	NUMBER
SECONDARY	Reciprocal (1/Serum Creatinine) of Serum Creatinine	Randomization to 5 years	Full analysis set=566	dL/mg/year	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Renal Composite Outcomes	Olmesartan Medoxomil		116	participants
Renal Composite Outcomes	Placebo Comparator		129	participants
Number of Participants Experiencing Cardiovascular Composite Outcomes	Olmesartan Medoxomil		40	participants
Number of Participants Experiencing Cardiovascular Composite Outcomes	Placebo Comparator		53	participants
The Change in Proteinuria	Olmesartan Medoxomil	12-week value	-19.5	Median percentage change in ratio
The Change in Proteinuria	Placebo Comparator	12-week value	12.6	Median percentage change in ratio
The Change in Proteinuria	Olmesartan Medoxomil	48-week value	-20.0	Median percentage change in ratio
The Change in Proteinuria	Placebo Comparator	48-week value	6.9	Median percentage change in ratio
The Change in Proteinuria	Olmesartan Medoxomil	144 -week value	-24.9	Median percentage change in ratio
The Change in Proteinuria	Placebo Comparator	144 -week value	3.1	Median percentage change in ratio

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Olmesartan Medoxomil	288
Overall Study	STARTED	Placebo Comparator	289
Overall Study	COMPLETED	Olmesartan Medoxomil	282
Overall Study	COMPLETED	Placebo Comparator	284
Overall Study	NOT COMPLETED	Olmesartan Medoxomil	6
Overall Study	NOT COMPLETED	Placebo Comparator	5

Source ClinicalTrials.gov

Adverse events718

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cataract	Eye disorders	Olmesartan Medoxomil	44	287
other	Cataract	Eye disorders	Placebo Comparator	45	288
other	Diabetic retinopathy	Eye disorders	Olmesartan Medoxomil	26	287
other	Diabetic retinopathy	Eye disorders	Placebo Comparator	24	288
other	Vitreous haemorrhage	Eye disorders	Olmesartan Medoxomil	12	287
other	Vitreous haemorrhage	Eye disorders	Placebo Comparator	16	288
other	Colonic polyp	Gastrointestinal disorders	Olmesartan Medoxomil	9	287
other	Colonic polyp	Gastrointestinal disorders	Placebo Comparator	17	288
other	Constipation	Gastrointestinal disorders	Olmesartan Medoxomil	49	287
other	Constipation	Gastrointestinal disorders	Placebo Comparator	41	288

1 to 10 of 718Source ClinicalTrials.gov

See all 718 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Olmesartan Medoxomil
Total, all-cause mortality	Placebo Comparator
Total, other adverse events	Olmesartan Medoxomil	264	287
Total, other adverse events	Placebo Comparator	265	288
Total, serious adverse events	Olmesartan Medoxomil	147	287
Total, serious adverse events	Placebo Comparator	171	288

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21993710	DERIVED	PubMed
24013685	DERIVED	PubMed
38682786	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Olmesartan Medoxomil vs Placebo Comparator: Renal Composite Outcomes	Trial comparisons
Olmesartan Medoxomil vs Placebo Comparator: Number of Participants Experiencing Cardiovascular Composite Outcomes	Trial comparisons
Olmesartan Medoxomil vs Placebo Comparator: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00141453

GET https://conductscience.org/api/trials/v1/NCT00141453/events?page=2

API reference For AI assistants