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Trial record 60 of 134 for:    OLMESARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00141453
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : May 10, 2011
Last Update Posted : May 10, 2011
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Diabetic Nephropathy
Type 2 Diabetes Mellitus
Proteinuria
Interventions Drug: olmesartan medoxomil
Drug: Placebo Tablets
Enrollment 577
Recruitment Details 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 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.
Arm/Group Title Olmesartan Medoxomil Placebo Comparator
Hide Arm/Group Description Experimental: Olmesartan medoxomil tablets 10mg to 40 mg Matching placebo tablets
Period Title: Overall Study
Started 288 289
Completed 282 284
Not Completed 6 5
Reason Not Completed
Protocol Violation             6             5
Arm/Group Title Olmesartan Medoxomil Placebo Comparator Total
Hide Arm/Group Description Experimental: Olmesartan medoxomil tablets 10mg to 40 mg Matching placebo tablets Total of all reporting groups
Overall Number of Baseline Participants 282 284 566
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 282 participants 284 participants 566 participants
59.1  (8.1) 59.2  (8.1) 59.2  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 282 participants 284 participants 566 participants
Female
83
  29.4%
92
  32.4%
175
  30.9%
Male
199
  70.6%
192
  67.6%
391
  69.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
East Asia Number Analyzed 282 participants 284 participants 566 participants
282 284 566
Use of ACE inhibitors  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 282 participants 284 participants 566 participants
Used ACE Inhibitors 205 209 414
Did not use ACE Inhibitors 77 75 152
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 282 participants 284 participants 566 participants
77.8  (10.4) 77.2  (10.6) 77.5  (10.5)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 282 participants 284 participants 566 participants
7.11  (1.20) 7.05  (1.24) 7.08  (1.22)
Serum creatinine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 282 participants 284 participants 566 participants
1.62  (0.32) 1.62  (0.35) 1.62  (0.34)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 282 participants 284 participants 566 participants
141.7  (17.0) 140.8  (18.0) 141.3  (17.5)
Urinary albumin:creatinine ratio  
Median (Inter-Quartile Range)
Unit of measure:  G/g
Number Analyzed 282 participants 284 participants 566 participants
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  
Median (Inter-Quartile Range)
Unit of measure:  G/g
Number Analyzed 282 participants 284 participants 566 participants
2.19
(0.99 to 3.87)
2.05
(1.10 to 3.80)
2.12
(1.03 to 3.82)
1.Primary Outcome
Title Renal Composite Outcomes
Hide Description first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
Time Frame Randomization to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set=566
Arm/Group Title Olmesartan Medoxomil Placebo Comparator
Hide Arm/Group Description:
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
Matching placebo tablets
Overall Number of Participants Analyzed 282 284
Measure Type: Number
Unit of Measure: participants
116 129
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan Medoxomil, Placebo Comparator
Comments We planned to collect 400 patients to detect 35% risk reduction for renal outcome in olmesartan group with 80% power at 2-sided .05 alpha level. The Cox regression model was applied to estimate the hazard ratios (HR)between treatment groups with 95% confidence intervals for the renal and cardiovascular composite event rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Regression, Cox
Comments The covariates were urinary albumin:creatinine ratio and serum creatinine at baseline & regions (Japan/Hong Kong) for the renal composite event rate.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval 95%
0.75 to 1.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Experiencing Cardiovascular Composite Outcomes
Hide Description 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.
Time Frame Within 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set=566
Arm/Group Title Olmesartan Medoxomil Placebo Comparator
Hide Arm/Group Description:
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
Matching placebo tablets
Overall Number of Participants Analyzed 282 284
Measure Type: Number
Unit of Measure: participants
40 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan Medoxomil, Placebo Comparator
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Regression, Cox
Comments Covariates baseline urinary albumin:creatinine ratio, age and history of cardiovascular disease for cardiovascular composite event rate.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.64
Confidence Interval 95%
0.43 to 0.98
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Change in Proteinuria
Hide Description The median percentage change from baseline value in urinary protein:creatinine ratio
Time Frame Randomization to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set=566
Arm/Group Title Olmesartan Medoxomil Placebo Comparator
Hide Arm/Group Description:
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
Matching placebo tablets
Overall Number of Participants Analyzed 282 284
Measure Type: Number
Unit of Measure: Median percentage change in ratio
12-week value -19.5 12.6
48-week value -20.0 6.9
144 -week value -24.9 3.1
4.Secondary Outcome
Title Reciprocal (1/Serum Creatinine) of Serum Creatinine
Hide Description 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.
Time Frame Randomization to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set=566
Arm/Group Title Olmesartan Medoxomil Placebo Comparator
Hide Arm/Group Description:
Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
Matching placebo tablets
Overall Number of Participants Analyzed 282 284
Median (Inter-Quartile Range)
Unit of Measure: dL/mg/year
-0.071
(-0.148 to -0.032)
-0.089
(-0.151 to -0.044)
Time Frame From baseline to up to 226 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olmesartan Medoxomil Placebo Comparator
Hide Arm/Group Description Experimental: Olmesartan medoxomil tablets 10mg to 40 mg Matching placebo tablets
All-Cause Mortality
Olmesartan Medoxomil Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Olmesartan Medoxomil Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   147/287 (51.22%)   171/288 (59.38%) 
Blood and lymphatic system disorders     
Anaemia  1  1/287 (0.35%)  6/288 (2.08%) 
Iron deficiency anaemia  1  0/287 (0.00%)  4/288 (1.39%) 
Lymphadenitis  1  1/287 (0.35%)  0/288 (0.00%) 
Neprogenic anaemia  1  0/287 (0.00%)  1/288 (0.35%) 
Cardiac disorders     
Acute myocardial infarction  1  25/287 (8.71%)  35/288 (12.15%) 
Angina pectoris  1  2/287 (0.70%)  2/288 (0.69%) 
Angina unstable  1  2/287 (0.70%)  2/288 (0.69%) 
Aortic valve stenosis  1  0/287 (0.00%)  1/288 (0.35%) 
Atrial fibrillation  1  1/287 (0.35%)  2/288 (0.69%) 
Antrioventricular block complete  1  0/287 (0.00%)  1/288 (0.35%) 
Atrioventricular block second degree  1  0/287 (0.00%)  1/288 (0.35%) 
Bradycardia  1  0/287 (0.00%)  1/288 (0.35%) 
Cardiac failure  1  3/287 (1.05%)  6/288 (2.08%) 
Cardiac failure acute  1  2/287 (0.70%)  7/288 (2.43%) 
Cardiac failure chronic  1  1/287 (0.35%)  0/288 (0.00%) 
Cardiac failure congestive  1  12/287 (4.18%)  12/288 (4.17%) 
Coronary artery disease  1  1/287 (0.35%)  0/288 (0.00%) 
Myocardial infarction  1  0/287 (0.00%)  1/288 (0.35%) 
Myocardial ischaemia  1  1/287 (0.35%)  2/288 (0.69%) 
Nodal arrhythmia  1  1/287 (0.35%)  0/288 (0.00%) 
Palpitations  1  0/287 (0.00%)  1/288 (0.35%) 
sick sinus syndrome  1  1/287 (0.35%)  1/288 (0.35%) 
supraventricular tachycardia  1  0/287 (0.00%)  1/288 (0.35%) 
tachycardia paroxysmal  1  0/287 (0.00%)  1/288 (0.35%) 
Ischaemic cardiomyopathy  1  0/287 (0.00%)  1/288 (0.35%) 
silent myocardial infarction  1  0/287 (0.00%)  1/288 (0.35%) 
Acute coronary syndrome  1  3/287 (1.05%)  4/288 (1.39%) 
Ear and labyrinth disorders     
Deafness neurosensory  1  1/287 (0.35%)  0/288 (0.00%) 
Vertigo  1  2/287 (0.70%)  1/288 (0.35%) 
vertigo positional  1  0/287 (0.00%)  1/288 (0.35%) 
sudden hearing loss  1  1/287 (0.35%)  0/288 (0.00%) 
Eye disorders     
angle closure glaucoma  1  1/287 (0.35%)  0/288 (0.00%) 
aphakia  1  1/287 (0.35%)  0/288 (0.00%) 
boardline glaucoma  1  1/287 (0.35%)  0/288 (0.00%) 
Cataract  1  12/287 (4.18%)  11/288 (3.82%) 
Cataract diabetic  1  0/287 (0.00%)  1/288 (0.35%) 
Diabetic retinal oedema  1  1/287 (0.35%)  0/288 (0.00%) 
Glaucoma  1  2/287 (0.70%)  0/288 (0.00%) 
macular oedema  1  1/287 (0.35%)  1/288 (0.35%) 
maculopathy  1  0/287 (0.00%)  1/288 (0.35%) 
retinal detachment  1  2/287 (0.70%)  3/288 (1.04%) 
retinal hemorrhage  1  0/287 (0.00%)  1/288 (0.35%) 
retinal tear  1  0/287 (0.00%)  1/288 (0.35%) 
retinopathy proliferative  1  1/287 (0.35%)  0/288 (0.00%) 
vitreous haemorrhage  1  7/287 (2.44%)  8/288 (2.78%) 
macular hole  1  0/287 (0.00%)  1/288 (0.35%) 
Gastrointestinal disorders     
Adominal distension  1  0/287 (0.00%)  1/288 (0.35%) 
abdominal pain  1  1/287 (0.35%)  0/288 (0.00%) 
abdominal pain lower  1  0/287 (0.00%)  1/288 (0.35%) 
anal fistula  1  1/287 (0.35%)  0/288 (0.00%) 
appendicitis perforated  1  1/287 (0.35%)  0/288 (0.00%) 
ascites  1  1/287 (0.35%)  1/288 (0.35%) 
colitis  1  1/287 (0.35%)  0/288 (0.00%) 
colonic polyp  1  5/287 (1.74%)  11/288 (3.82%) 
constipation  1  0/287 (0.00%)  1/288 (0.35%) 
diarroea  1  0/287 (0.00%)  3/288 (1.04%) 
duodenal polyp  1  1/287 (0.35%)  0/288 (0.00%) 
duodenal ulcer  1  1/287 (0.35%)  0/288 (0.00%) 
duodenal ulcer haemorrhage  1  1/287 (0.35%)  0/288 (0.00%) 
entrocolitis  1  1/287 (0.35%)  0/288 (0.00%) 
gastric ulcer  1  1/287 (0.35%)  1/288 (0.35%) 
gastric ulcer haemorrhage  1  2/287 (0.70%)  0/288 (0.00%) 
gastritis  1  2/287 (0.70%)  2/288 (0.69%) 
gastritis erosive  1  0/287 (0.00%)  1/288 (0.35%) 
gastritis haemorrhagic  1  0/287 (0.00%)  1/288 (0.35%) 
haemorrhoids  1  1/287 (0.35%)  1/288 (0.35%) 
inguinal hernia  1  0/287 (0.00%)  1/288 (0.35%) 
intestinal obstruction  1  1/287 (0.35%)  2/288 (0.69%) 
Mallory-Weiss syndrome  1  1/287 (0.35%)  2/288 (0.69%) 
Melaena  1  1/287 (0.35%)  0/288 (0.00%) 
Nausea  1  0/287 (0.00%)  1/288 (0.35%) 
Oesophagitis  1  0/287 (0.00%)  2/288 (0.69%) 
Pancreatitis acute  1  0/287 (0.00%)  1/288 (0.35%) 
Peptic ulcer  1  0/287 (0.00%)  1/288 (0.35%) 
Salivary gland calculus  1  0/287 (0.00%)  1/288 (0.35%) 
Stomach discomfort  1  1/287 (0.35%)  0/288 (0.00%) 
Umbilical hernia  1  1/287 (0.35%)  0/288 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/287 (0.00%)  1/288 (0.35%) 
Varices oesophageal  1  0/287 (0.00%)  2/288 (0.69%) 
General disorders     
Chest discomfort  1  1/287 (0.35%)  0/288 (0.00%) 
Chest pain  1  4/287 (1.39%)  1/288 (0.35%) 
Chills  1  1/287 (0.35%)  0/288 (0.00%) 
Generalised oedema  1  1/287 (0.35%)  3/288 (1.04%) 
Hernia  1  0/287 (0.00%)  1/288 (0.35%) 
Malaise  1  0/287 (0.00%)  1/288 (0.35%) 
Oedema  1  2/287 (0.70%)  2/288 (0.69%) 
Oedema peripheral  1  0/287 (0.00%)  3/288 (1.04%) 
Sudden death  1  3/287 (1.05%)  3/288 (1.04%) 
Hepatobiliary disorders     
Bile duct stone  1  1/287 (0.35%)  1/288 (0.35%) 
Cholecystitis chronic  1  0/287 (0.00%)  1/288 (0.35%) 
Cholelithiasis  1  1/287 (0.35%)  0/288 (0.00%) 
Cirrhosis alcoholic  1  0/287 (0.00%)  1/288 (0.35%) 
Hepatic function abnormal  1  0/287 (0.00%)  2/288 (0.69%) 
Hepatitis  1  0/287 (0.00%)  1/288 (0.35%) 
Immune system disorders     
Anaphylactic shock  1  1/287 (0.35%)  0/288 (0.00%) 
Infections and infestations     
Appendicitis  1  1/287 (0.35%)  2/288 (0.69%) 
Arthritis viral  1  0/287 (0.00%)  1/288 (0.35%) 
Bartholin's abscess  1  0/287 (0.00%)  1/288 (0.35%) 
Bronchitis  1  0/287 (0.00%)  2/288 (0.69%) 
Bronchopneumonia  1  0/287 (0.00%)  1/288 (0.35%) 
Cellulitis  1  5/287 (1.74%)  4/288 (1.39%) 
Diabetic gangrene  1  1/287 (0.35%)  0/288 (0.00%) 
Gangrene  1  2/287 (0.70%)  0/288 (0.00%) 
Gastroenteritis  1  7/287 (2.44%)  3/288 (1.04%) 
Gastroenteritis viral  1  0/287 (0.00%)  1/288 (0.35%) 
Hepatitis C  1  0/287 (0.00%)  1/288 (0.35%) 
Herpes zoster  1  1/287 (0.35%)  1/288 (0.35%) 
HIV infection  1  0/287 (0.00%)  1/288 (0.35%) 
Infected sebaceous cyst  1  1/287 (0.35%)  0/288 (0.00%) 
Influenza  1  1/287 (0.35%)  0/288 (0.00%) 
Lobar pneumonia  1  1/287 (0.35%)  0/288 (0.00%) 
Lower respiratory tract infection  1  5/287 (1.74%)  6/288 (2.08%) 
Nasopharyngitis  1  1/287 (0.35%)  1/288 (0.35%) 
Otitis media  1  0/287 (0.00%)  1/288 (0.35%) 
Perianal abscess  1  0/287 (0.00%)  1/288 (0.35%) 
Pneumonia  1  5/287 (1.74%)  8/288 (2.78%) 
Postoperative wound infection  1  0/287 (0.00%)  1/288 (0.35%) 
Pyothorax  1  0/287 (0.00%)  1/288 (0.35%) 
Sepsis  1  0/287 (0.00%)  4/288 (1.39%) 
Sialoadenitis  1  0/287 (0.00%)  1/288 (0.35%) 
Subcutaneous abscess  1  1/287 (0.35%)  0/288 (0.00%) 
Upper respiratory tract infection  1  0/287 (0.00%)  4/288 (1.39%) 
Urinary tract infection  1  7/287 (2.44%)  6/288 (2.08%) 
Urosepsis  1  0/287 (0.00%)  1/288 (0.35%) 
Abscess limb  1  1/287 (0.35%)  1/288 (0.35%) 
Enteritis infectious  1  2/287 (0.70%)  0/288 (0.00%) 
Injury, poisoning and procedural complications     
Facial bones fracture  1  1/287 (0.35%)  0/288 (0.00%) 
Femur fracture  1  1/287 (0.35%)  0/288 (0.00%) 
Fracture  1  1/287 (0.35%)  1/288 (0.35%) 
Humerus fracture  1  0/287 (0.00%)  1/288 (0.35%) 
Overdose  1  1/287 (0.35%)  1/288 (0.35%) 
Patella fracture  1  0/287 (0.00%)  1/288 (0.35%) 
Radius fracture  1  1/287 (0.35%)  0/288 (0.00%) 
Skull fractured base  1  1/287 (0.35%)  0/288 (0.00%) 
Spinal cord injury cervical  1  1/287 (0.35%)  0/288 (0.00%) 
Subdural haematoma  1  0/287 (0.00%)  1/288 (0.35%) 
Subdural haemorrhage  1  1/287 (0.35%)  0/288 (0.00%) 
Traumatic fracture  1  0/287 (0.00%)  1/288 (0.35%) 
Excoriation  1  0/287 (0.00%)  1/288 (0.35%) 
Contusion  1  1/287 (0.35%)  0/288 (0.00%) 
Intraocular lens dislocation  1  0/287 (0.00%)  1/288 (0.35%) 
Brain contusion  1  0/287 (0.00%)  1/288 (0.35%) 
Thermal burn  1  0/287 (0.00%)  1/288 (0.35%) 
Eye injury  1  0/287 (0.00%)  1/288 (0.35%) 
Neck injury  1  0/287 (0.00%)  1/288 (0.35%) 
Medical device site reaction  1  0/287 (0.00%)  1/288 (0.35%) 
Ligament rupture  1  0/287 (0.00%)  1/288 (0.35%) 
Investigations     
Alanine aminotransferase increased  1  1/287 (0.35%)  3/288 (1.04%) 
Arteriogram coronary  1  1/287 (0.35%)  1/288 (0.35%) 
Aspartate aminotransferase increased  1  1/287 (0.35%)  3/288 (1.04%) 
Bilirubin conjugated increased  1  0/287 (0.00%)  1/288 (0.35%) 
Blood bilirubin increased  1  1/287 (0.35%)  1/288 (0.35%) 
Blood calcium decreased  1  0/287 (0.00%)  1/288 (0.35%) 
Blood chloride decreased  1  0/287 (0.00%)  1/288 (0.35%) 
Blood creatine phosphokinase increased  1  2/287 (0.70%)  5/288 (1.74%) 
Blood creatinine increased  1  12/287 (4.18%)  15/288 (5.21%) 
Blood glucose decreased  1  2/287 (0.70%)  5/288 (1.74%) 
Blood glucose increased  1  2/287 (0.70%)  2/288 (0.69%) 
Blood lactate dehydrogenase increased  1  0/287 (0.00%)  1/288 (0.35%) 
Blood potassium decreased  1  1/287 (0.35%)  0/288 (0.00%) 
Blood potassium increased  1  0/287 (0.00%)  2/288 (0.69%) 
Blood pressure increased  1  1/287 (0.35%)  0/288 (0.00%) 
Blood urea increased  1  6/287 (2.09%)  7/288 (2.43%) 
C-reactive protein increased  1  3/287 (1.05%)  3/288 (1.04%) 
Colonoscopy  1  0/287 (0.00%)  2/288 (0.69%) 
Gamma-glutamyltransferase increased  1  1/287 (0.35%)  2/288 (0.69%) 
Glycosylated haemoglobin increased  1  1/287 (0.35%)  1/288 (0.35%) 
Haematocrit decreased  1  2/287 (0.70%)  4/288 (1.39%) 
Haemoglobin decreased  1  3/287 (1.05%)  5/288 (1.74%) 
International normalised ratio increased  1  0/287 (0.00%)  1/288 (0.35%) 
Myoglobin blood increased  1  0/287 (0.00%)  1/288 (0.35%) 
Neutrophil count increased  1  0/287 (0.00%)  1/288 (0.35%) 
Nuclear magnetic resonance imaging brain abnormal  1  1/287 (0.35%)  0/288 (0.00%) 
Red blood cell count decreased  1  2/287 (0.70%)  4/288 (1.39%) 
Serum ferritin decreased  1  0/287 (0.00%)  1/288 (0.35%) 
Weight increased  1  2/287 (0.70%)  1/288 (0.35%) 
White blood cell count increased  1  3/287 (1.05%)  2/288 (0.69%) 
Blood phosphorus increased  1  0/287 (0.00%)  3/288 (1.04%) 
Creatinine urine increased  1  1/287 (0.35%)  0/288 (0.00%) 
Sleep study  1  5/287 (1.74%)  1/288 (0.35%) 
Brain natriuretic peptide increased  1  0/287 (0.00%)  1/288 (0.35%) 
Urine protein/creatinine ratio decreased  1  1/287 (0.35%)  0/288 (0.00%) 
Urine protein/creatinine ratio increased  1  0/287 (0.00%)  1/288 (0.35%) 
Cardiac function test  1  0/287 (0.00%)  1/288 (0.35%) 
Blood alkaline phosphatase increased  1  1/287 (0.35%)  3/288 (1.04%) 
Dexamethasone suppression test positive  1  0/287 (0.00%)  2/288 (0.69%) 
Dexamethasone suppression test  1  1/287 (0.35%)  1/288 (0.35%) 
Renal function test  1  1/287 (0.35%)  0/288 (0.00%) 
Pulmonary function test abnormal  1  1/287 (0.35%)  0/288 (0.00%) 
Endoscopy large bowel  1  1/287 (0.35%)  0/288 (0.00%) 
Investigation  1  1/287 (0.35%)  1/288 (0.35%) 
Nephrological examination  1  1/287 (0.35%)  0/288 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  0/287 (0.00%)  1/288 (0.35%) 
Dehydration  1  1/287 (0.35%)  2/288 (0.69%) 
Diabetes mellitus inadequate control  1  7/287 (2.44%)  8/288 (2.78%) 
Diabetic ketoacidosis  1  0/287 (0.00%)  1/288 (0.35%) 
Fluid overload  1  5/287 (1.74%)  10/288 (3.47%) 
Fluid retention  1  3/287 (1.05%)  1/288 (0.35%) 
Gout  1  1/287 (0.35%)  1/288 (0.35%) 
Hyperglycaemia  1  4/287 (1.39%)  4/288 (1.39%) 
Hyperkalaemia  1  10/287 (3.48%)  6/288 (2.08%) 
Hypocalcaemia  1  0/287 (0.00%)  1/288 (0.35%) 
Hypoglycaemia  1  8/287 (2.79%)  15/288 (5.21%) 
Hypoglycaemia unawareness  1  1/287 (0.35%)  0/288 (0.00%) 
Hypokalaemia  1  1/287 (0.35%)  0/288 (0.00%) 
Hyponatraemia  1  1/287 (0.35%)  1/288 (0.35%) 
Metabolic acidosis  1  0/287 (0.00%)  2/288 (0.69%) 
Diabetic foot  1  0/287 (0.00%)  1/288 (0.35%) 
Decreased appetite  1  0/287 (0.00%)  1/288 (0.35%) 
Musculoskeletal and connective tissue disorders     
Amyotrophy  1  1/287 (0.35%)  0/288 (0.00%) 
Back pain  1  1/287 (0.35%)  1/288 (0.35%) 
Gouty arthritis  1  2/287 (0.70%)  1/288 (0.35%) 
Joint contracture  1  1/287 (0.35%)  0/288 (0.00%) 
Lumbar spinal stenosis  1  1/287 (0.35%)  1/288 (0.35%) 
Myositis  1  1/287 (0.35%)  1/288 (0.35%) 
Neuropathic arthropathy  1  1/287 (0.35%)  0/288 (0.00%) 
Periarthritis  1  0/287 (0.00%)  1/288 (0.35%) 
Rhabdomyolysis  1  0/287 (0.00%)  2/288 (0.69%) 
Spinal osteoarthritis  1  2/287 (0.70%)  0/288 (0.00%) 
Synovitis  1  0/287 (0.00%)  1/288 (0.35%) 
Tenosynovitis  1  1/287 (0.35%)  0/288 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/287 (0.00%)  1/288 (0.35%) 
Carcinoid tumour of the gastrointestinal tract  1  1/287 (0.35%)  0/288 (0.00%) 
Colon cancer  1  0/287 (0.00%)  2/288 (0.69%) 
Gastric cancer  1  1/287 (0.35%)  2/288 (0.69%) 
Hepatic neoplasm  1  0/287 (0.00%)  1/288 (0.35%) 
Hepatic neoplasm malignant  1  0/287 (0.00%)  1/288 (0.35%) 
Metastases to liver  1  0/287 (0.00%)  1/288 (0.35%) 
Non-Hodgkin's lymphoma  1  1/287 (0.35%)  0/288 (0.00%) 
Small cell lung cancer stage unspecified  1  0/287 (0.00%)  1/288 (0.35%) 
Lung neoplasm malignant  1  0/287 (0.00%)  1/288 (0.35%) 
Large intestine carcinoma  1  1/287 (0.35%)  2/288 (0.69%) 
Prostate cancer  1  0/287 (0.00%)  1/288 (0.35%) 
Pituitary tumour benign  1  0/287 (0.00%)  1/288 (0.35%) 
Non-small cell lung cancer  1  1/287 (0.35%)  0/288 (0.00%) 
Lung neoplasm  1  0/287 (0.00%)  1/288 (0.35%) 
Nervous system disorders     
Altered state of consciousness  1  0/287 (0.00%)  1/288 (0.35%) 
Cerebellar infarction  1  2/287 (0.70%)  2/288 (0.69%) 
Cerebrovascular accident  1  1/287 (0.35%)  1/288 (0.35%) 
Convulsion  1  0/287 (0.00%)  1/288 (0.35%) 
Diabetic autonomic neuropathy  1  1/287 (0.35%)  0/288 (0.00%) 
Dizziness  1  3/287 (1.05%)  1/288 (0.35%) 
Dizziness postural  1  0/287 (0.00%)  1/288 (0.35%) 
Epilepsy  1  1/287 (0.35%)  0/288 (0.00%) 
Intracranial aneurysm  1  0/287 (0.00%)  1/288 (0.35%) 
Loss of consciousness  1  2/287 (0.70%)  0/288 (0.00%) 
Thrombotic cerebral infarction  1  0/287 (0.00%)  1/288 (0.35%) 
Syncope  1  0/287 (0.00%)  3/288 (1.04%) 
Mononeuropathy multiplex  1  0/287 (0.00%)  1/288 (0.35%) 
Syncope vasovagal  1  1/287 (0.35%)  0/288 (0.00%) 
Vertebrobasilar insufficiency  1  1/287 (0.35%)  0/288 (0.00%) 
VIth nerve paralysis  1  1/287 (0.35%)  0/288 (0.00%) 
Cubital tunnel syndrome  1  0/287 (0.00%)  1/288 (0.35%) 
Cranial nerve paralysis  1  0/287 (0.00%)  1/288 (0.35%) 
Psychiatric disorders     
Completed suicide  1  1/287 (0.35%)  1/288 (0.35%) 
Confusional state  1  0/287 (0.00%)  1/288 (0.35%) 
Depression  1  1/287 (0.35%)  0/288 (0.00%) 
Dysthymic disorder  1  0/287 (0.00%)  1/288 (0.35%) 
Psychosomatic disease  1  1/287 (0.35%)  0/288 (0.00%) 
Renal and urinary disorders     
Azotaemia  1  1/287 (0.35%)  1/288 (0.35%) 
Nephropathy toxic  1  1/287 (0.35%)  0/288 (0.00%) 
Nephrotic syndrome  1  1/287 (0.35%)  0/288 (0.00%) 
Neurogenic bladder  1  0/287 (0.00%)  1/288 (0.35%) 
Renal failure  1  1/287 (0.35%)  0/288 (0.00%) 
Renal failure acute  1  7/287 (2.44%)  3/288 (1.04%) 
Renal failure chronic  1  4/287 (1.39%)  2/288 (0.69%) 
Urinary retention  1  0/287 (0.00%)  1/288 (0.35%) 
Diabetic nephropathy  1  2/287 (0.70%)  2/288 (0.69%) 
Renal impairment  1  4/287 (1.39%)  2/288 (0.69%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  2/287 (0.70%)  0/288 (0.00%) 
Epididymitis  1  1/287 (0.35%)  1/288 (0.35%) 
Prostatomegaly  1  2/287 (0.70%)  0/288 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  0/287 (0.00%)  1/288 (0.35%) 
Asthma  1  1/287 (0.35%)  0/288 (0.00%) 
Asthma late onset  1  0/287 (0.00%)  1/288 (0.35%) 
Chronic obstructive pulmonary disease  1  1/287 (0.35%)  0/288 (0.00%) 
Dyspnoea  1  1/287 (0.35%)  0/288 (0.00%) 
Epistaxis  1  0/287 (0.00%)  1/288 (0.35%) 
Haemoptysis  1  1/287 (0.35%)  1/288 (0.35%) 
Haemothorax  1  0/287 (0.00%)  1/288 (0.35%) 
Laryngeal oedema  1  0/287 (0.00%)  1/288 (0.35%) 
Pleural effusion  1  3/287 (1.05%)  1/288 (0.35%) 
Pleural fibrosis  1  0/287 (0.00%)  1/288 (0.35%) 
Pleurisy  1  0/287 (0.00%)  1/288 (0.35%) 
Pneumonia aspiration  1  0/287 (0.00%)  1/288 (0.35%) 
Pulmonary congestion  1  1/287 (0.35%)  0/288 (0.00%) 
Pulmonary oedema  1  2/287 (0.70%)  0/288 (0.00%) 
Sleep apnoea syndrome  1  3/287 (1.05%)  1/288 (0.35%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  0/287 (0.00%)  1/288 (0.35%) 
Dermatitis  1  0/287 (0.00%)  1/288 (0.35%) 
Eczema  1  0/287 (0.00%)  1/288 (0.35%) 
Skin ulcer  1  2/287 (0.70%)  0/288 (0.00%) 
Urticaria  1  1/287 (0.35%)  0/288 (0.00%) 
Surgical and medical procedures     
Catheterisation cardiac  1  1/287 (0.35%)  4/288 (1.39%) 
Uterine prolapse repair  1  1/287 (0.35%)  0/288 (0.00%) 
Vitrectomy  1  1/287 (0.35%)  0/288 (0.00%) 
Glaucoma surgery  1  1/287 (0.35%)  0/288 (0.00%) 
Coronary angioplasty  1  2/287 (0.70%)  2/288 (0.69%) 
Continuous positive airway pressure  1  1/287 (0.35%)  1/288 (0.35%) 
Hospitalisation  1  3/287 (1.05%)  3/288 (1.04%) 
Surgical vascular shunt  1  0/287 (0.00%)  1/288 (0.35%) 
Elective surgery  1  0/287 (0.00%)  1/288 (0.35%) 
Arteriovenous shunt operation  1  2/287 (0.70%)  2/288 (0.69%) 
Tooth extraction  1  1/287 (0.35%)  0/288 (0.00%) 
Cataract operation  1  9/287 (3.14%)  13/288 (4.51%) 
Blood pressure management  1  1/287 (0.35%)  0/288 (0.00%) 
Percutaneous coronary intervention  1  0/287 (0.00%)  1/288 (0.35%) 
Vascular disorders     
Aortic aneurysm  1  0/287 (0.00%)  1/288 (0.35%) 
Arteriosclerosis  1  1/287 (0.35%)  0/288 (0.00%) 
Hypertension  1  0/287 (0.00%)  1/288 (0.35%) 
Hypotension  1  4/287 (1.39%)  1/288 (0.35%) 
Orthostatic hypotension  1  0/287 (0.00%)  2/288 (0.69%) 
Peripheral vascular disorder  1  0/287 (0.00%)  1/288 (0.35%) 
Deep vein thrombosis  1  1/287 (0.35%)  0/288 (0.00%) 
Blood pressure inadequately controlled  1  2/287 (0.70%)  0/288 (0.00%) 
Arteriosclerosis obliterans  1  0/287 (0.00%)  1/288 (0.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olmesartan Medoxomil Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   264/287 (91.99%)   265/288 (92.01%) 
Eye disorders     
Cataract  1  44/287 (15.33%)  45/288 (15.63%) 
Diabetic retinopathy  1  26/287 (9.06%)  24/288 (8.33%) 
Vitreous haemorrhage  1  12/287 (4.18%)  16/288 (5.56%) 
Gastrointestinal disorders     
Colonic polyp  1  9/287 (3.14%)  17/288 (5.90%) 
Constipation  1  49/287 (17.07%)  41/288 (14.24%) 
Diarrhoea  1  28/287 (9.76%)  40/288 (13.89%) 
Gastritis  1  16/287 (5.57%)  19/288 (6.60%) 
Nausea  1  15/287 (5.23%)  12/288 (4.17%) 
Toothache  1  16/287 (5.57%)  16/288 (5.56%) 
General disorders     
Chest discomfort  1  16/287 (5.57%)  18/288 (6.25%) 
Chest pain  1  19/287 (6.62%)  9/288 (3.13%) 
Malaise  1  7/287 (2.44%)  16/288 (5.56%) 
Oedema  1  17/287 (5.92%)  20/288 (6.94%) 
Oedema peripheral  1  65/287 (22.65%)  76/288 (26.39%) 
Infections and infestations     
Bronchitis  1  21/287 (7.32%)  22/288 (7.64%) 
Gastroenteritis  1  26/287 (9.06%)  14/288 (4.86%) 
Infuenza  1  15/287 (5.23%)  11/288 (3.82%) 
Nasopharyngitis  1  105/287 (36.59%)  106/288 (36.81%) 
Upper respiratory tract infection  1  59/287 (20.56%)  57/288 (19.79%) 
Urinary tract infection  1  19/287 (6.62%)  17/288 (5.90%) 
Injury, poisoning and procedural complications     
Contusion  1  25/287 (8.71%)  16/288 (5.56%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  13/287 (4.53%)  15/288 (5.21%) 
Gout  1  18/287 (6.27%)  16/288 (5.56%) 
Hyperkalaemia  1  68/287 (23.69%)  61/288 (21.18%) 
Hypoglycaemia  1  69/287 (24.04%)  69/288 (23.96%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  40/287 (13.94%)  33/288 (11.46%) 
Back pain  1  47/287 (16.38%)  42/288 (14.58%) 
Muscle spasms  1  21/287 (7.32%)  37/288 (12.85%) 
Musculoskeletal pain  1  19/287 (6.62%)  22/288 (7.64%) 
Pain in extremity  1  28/287 (9.76%)  34/288 (11.81%) 
Spinal osteoarthritis  1  19/287 (6.62%)  17/288 (5.90%) 
Nervous system disorders     
Dizziness  1  41/287 (14.29%)  50/288 (17.36%) 
Dizziness postural  1  14/287 (4.88%)  17/288 (5.90%) 
Headache  1  26/287 (9.06%)  24/288 (8.33%) 
Hypoaesthesia  1  18/287 (6.27%)  19/288 (6.60%) 
Psychiatric disorders     
Insomnia  1  20/287 (6.97%)  17/288 (5.90%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  60/287 (20.91%)  57/288 (19.79%) 
Epistaxis  1  9/287 (3.14%)  17/288 (5.90%) 
Rhinorrhoea  1  15/287 (5.23%)  15/288 (5.21%) 
Upper respiratory tract inflammation  1  37/287 (12.89%)  23/288 (7.99%) 
Skin and subcutaneous tissue disorders     
Eczema  1  27/287 (9.41%)  27/288 (9.38%) 
Pruritus  1  21/287 (7.32%)  25/288 (8.68%) 
Vascular disorders     
Hypotension  1  15/287 (5.23%)  6/288 (2.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
Results of Study shall not be published without prior express written consent and approval of Sponsor. Sponsor has right to change proposed publication and/or prohibit publication and Contractor must comply with requirements of Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Howard Kessler
Organization: Daiichi Sankyo, Inc
Phone: 732-590-5032
EMail: hmkessler@dsi.com
Layout table for additonal information
Responsible Party: Shuji Tsukiyama, Daiichi Sankyo Co., Ltd. Tokyo, Japan
ClinicalTrials.gov Identifier: NCT00141453     History of Changes
Other Study ID Numbers: ORIENT
First Submitted: August 31, 2005
First Posted: September 1, 2005
Results First Submitted: August 31, 2009
Results First Posted: May 10, 2011
Last Update Posted: May 10, 2011