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Trial record 78 of 134 for:    OLMESARTAN

Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension

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: NCT00649389
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : September 1, 2010
Last Update Posted : January 9, 2019
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
Condition Hypertension
Interventions Drug: Olmesartan medoxomil
Drug: Amlodipine
Drug: Hydrochlorothiazide
Enrollment 2500
Recruitment Details First subject first visit 12 May 2008. Last subject last follow-up 27 Feb 2009. 317 sites in USA and Puerto Rico. Planned: 2400 subjects (600 per treatment arm). Enrolled: 6724 subjects. Randomized: 2492 subjects.
Pre-assignment Details Duration of the study was 57 weeks with 52 weeks of treatment. This included 3-week stabilization/washout (Period I), 12-week double blind treatment (Period II), 40 week open label treatment (Period III), and 2-week post treatment follow-up (Period IV).
Arm/Group Title OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25
Hide Arm/Group Description Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily. Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily. Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily. Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
Period Title: Overall Study
Started 628 637 600 627
Completed 557 531 512 516
Not Completed 71 106 88 111
Reason Not Completed
Adverse Event             22             46             38             48
Lost to Follow-up             15             17             21             26
Protocol Violation             11             13             9             8
Withdrawal by Subject             20             21             19             23
Other             3             9             1             6
Arm/Group Title OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25 Total
Hide Arm/Group Description Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily. Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily. Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily. Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily. Total of all reporting groups
Overall Number of Baseline Participants 628 637 600 627 2492
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 628 participants 637 participants 600 participants 627 participants 2492 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
508
  80.9%
505
  79.3%
504
  84.0%
504
  80.4%
2021
  81.1%
>=65 years
120
  19.1%
132
  20.7%
96
  16.0%
123
  19.6%
471
  18.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 628 participants 637 participants 600 participants 627 participants 2492 participants
55.1  (10.93) 55.9  (10.78) 54.6  (10.82) 54.7  (11.22) 55.1  (10.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 628 participants 637 participants 600 participants 627 participants 2492 participants
Female
303
  48.2%
298
  46.8%
266
  44.3%
307
  49.0%
1174
  47.1%
Male
325
  51.8%
339
  53.2%
334
  55.7%
320
  51.0%
1318
  52.9%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 628 participants 637 participants 600 participants 627 participants 2492 participants
American Indian/Alaskan Native 3 1 4 1 9
Asian 13 10 7 19 49
Hawaiian/Pacific Islander 0 1 1 2 4
Black/African American 181 200 192 184 757
White 431 421 391 415 1658
Unknown or Not Reported 0 4 5 6 15
[1]
Measure Description: Race of participants as selected by participant. Participants were allowed to choose more than one race category; therefore, the total for an arm may be greater than the number of participants
Diabetes Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 628 participants 637 participants 600 participants 627 participants 2492 participants
Diabetic 100 99 92 96 387
Not diabetic 528 538 508 531 2105
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 628 participants 637 participants 600 participants 627 participants 2492 participants
95.9  (22.65) 96.1  (22.55) 96.1  (23.41) 96.0  (23.24) 96.0  (22.94)
Body Mass Index  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 628 participants 637 participants 600 participants 627 participants 2492 participants
Less than 30 kg/m2 229 238 230 240 937
Greater than or equal to 30 kg/m2 399 399 370 387 1555
Duration of hypertension  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 628 participants 637 participants 600 participants 627 participants 2492 participants
10.12  (9.865) 10.34  (9.826) 9.73  (8.983) 9.54  (9.558) 9.94  (9.571)
1.Primary Outcome
Title Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).
Hide Description [Not Specified]
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of SeDBP
Arm/Group Title OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25
Hide Arm/Group Description:
Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
Overall Number of Participants Analyzed 624 627 593 614
Mean (Standard Deviation)
Unit of Measure: mm Hg
-17.8  (9.47) -16.5  (10.84) -14.8  (8.78) -21.5  (10.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM40/AML10, OM40/AML10/HCTZ25
Comments All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM40/HCTZ25, OM40/AML10/HCTZ25
Comments All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AML10/HCTZ25, OM40/AML10/HCTZ25
Comments All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of seated diastolic blood pressure
Arm/Group Title OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25
Hide Arm/Group Description:
Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
Overall Number of Participants Analyzed 624 627 593 614
Measure Type: Number
Unit of Measure: Percentage of subjects
46.0 46.6 34.9 64.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM40/AML10, OM40/AML10/HCTZ25
Comments Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM40/HCTZ25, OM40/AML10/HCTZ25
Comments Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AML10/HCTZ25, OM40/AML10/HCTZ25
Comments Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination
Hide Description [Not Specified]
Time Frame Baseline to 12 weeks or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
The ABPM Analysis Set included 440 subjects who provided consent to participate in the ABPM sub-study and who were to provide ABPM measurements prior to and after randomization. Those analyzed is the number who had values at both baseline and 12 weeks or early termination
Arm/Group Title OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25
Hide Arm/Group Description:
Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
Overall Number of Participants Analyzed 96 101 83 100
Mean (Standard Deviation)
Unit of Measure: mm Hg
Diastolic blood pressure -13.9  (8.09) -14.5  (8.73) -10.7  (7.46) -18.0  (8.11)
Systolic blood pressure -23.5  (11.80) -23.9  (13.10) -18.5  (10.67) -30.3  (13.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM40/AML10, OM40/AML10/HCTZ25
Comments Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM40/HCTZ25, OM40/AML10/HCTZ25
Comments Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AML10/HCTZ25, OM40/AML10/HCTZ25
Comments Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OM40/AML10, OM40/AML10/HCTZ25
Comments Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OM40/HCTZ25, OM40/AML10/HCTZ25
Comments Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection AML10/HCTZ25, OM40/AML10/HCTZ25
Comments Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change in Seated Systolic Blood Pressure From Baseline to Week 12
Hide Description [Not Specified]
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25
Hide Arm/Group Description:
Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
Overall Number of Participants Analyzed 624 627 593 614
Mean (Standard Deviation)
Unit of Measure: mm Hg
-31.1  (15.44) -31.2  (18.58) -28.9  (15.12) -38.1  (17.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM40/AML10, OM40/AML10/HCTZ25
Comments All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM40/HCTZ25, OM40/AML10/HCTZ25
Comments All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AML10/HCTZ25, OM40/AML10/HCTZ25
Comments All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description Safety was assessed at all study visits. Variables included adverse events, clinical laboratory tests, vital signs, ECGs, and physical examinations. The assessment of causality was based on the investigator's judgment.
 
Arm/Group Title OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25
Hide Arm/Group Description Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily. Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily. Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily. Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
All-Cause Mortality
OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/596 (1.51%)   7/580 (1.21%)   9/552 (1.63%)   10/574 (1.74%) 
Cardiac disorders         
coronary artery disease  2  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  2/574 (0.35%) 
acute myocardial infarction  2  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
angina pectoris  2  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
right ventricular failure  2  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
Congenital, familial and genetic disorders         
pulmonary artery atresia  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
Gastrointestinal disorders         
duodenitis  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
gastritis  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
gastrointstial haemhorrhage  2  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
hiatus hernia  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
rectal haemhorrhage  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
General disorders         
non-cardiac chest pain  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  1/574 (0.17%) 
Immune system disorders         
hypersensitivity  2  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
Infections and infestations         
appendicitis  1  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
arthritis bacterial  2  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
cellulitis  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
lobar pneumonia  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
osteomyelitis  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
pyelonephritis  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
sepsis  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
Injury, poisoning and procedural complications         
fall  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
hip fracture  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
vertebral injury  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
Metabolism and nutrition disorders         
diabetes mellitus  2  0/596 (0.00%)  1/580 (0.17%)  0/552 (0.00%)  0/574 (0.00%) 
hypokalemia  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
hyponatraemia  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
Musculoskeletal and connective tissue disorders         
osteoarthritis  2  2/596 (0.34%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
intervertebral disc degeneration  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
musculoskeletal chest pain  2  0/596 (0.00%)  1/580 (0.17%)  0/552 (0.00%)  0/574 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
prostate cancer  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  2/574 (0.35%) 
bladder cancer  2  0/596 (0.00%)  1/580 (0.17%)  0/552 (0.00%)  0/574 (0.00%) 
colon cancer  2  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
renal cell carcinoma  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
Nervous system disorders         
cerebrovasular accident  2  0/596 (0.00%)  2/580 (0.34%)  0/552 (0.00%)  0/574 (0.00%) 
ataxia  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
cerebellar infarction  2  0/596 (0.00%)  1/580 (0.17%)  0/552 (0.00%)  0/574 (0.00%) 
hemiparesis  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
peroneal nerve palsy  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
syncope  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
Renal and urinary disorders         
acute prerenal failure  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
hydronephrosis  2  0/596 (0.00%)  0/580 (0.00%)  1/552 (0.18%)  0/574 (0.00%) 
Reproductive system and breast disorders         
ovarian cyst  2  0/596 (0.00%)  1/580 (0.17%)  0/552 (0.00%)  0/574 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
dyspnoea  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
obstructive airways disorder  2  0/596 (0.00%)  0/580 (0.00%)  0/552 (0.00%)  1/574 (0.17%) 
sleep apnoea syndrome  2  1/596 (0.17%)  0/580 (0.00%)  0/552 (0.00%)  0/574 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
2
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 3%
OM40/AML10 OM40/HCTZ25 AML10/HCTZ25 OM40/AML10/HCTZ25
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   210/596 (35.23%)   210/580 (36.21%)   212/552 (38.41%)   237/574 (41.29%) 
Gastrointestinal disorders         
nausea  1  12/596 (2.01%)  22/580 (3.79%)  12/552 (2.17%)  17/574 (2.96%) 
General disorders         
edema peripheral  1  42/596 (7.05%)  6/580 (1.03%)  46/552 (8.33%)  44/574 (7.67%) 
fatigue  1  34/596 (5.70%)  31/580 (5.34%)  36/552 (6.52%)  24/574 (4.18%) 
Infections and infestations         
upper respiratory tract infection  1  26/596 (4.36%)  18/580 (3.10%)  14/552 (2.54%)  16/574 (2.79%) 
nasopharyngitis  1  11/596 (1.85%)  20/580 (3.45%)  16/552 (2.90%)  20/574 (3.48%) 
Metabolism and nutrition disorders         
hypokalemia  1  2/596 (0.34%)  3/580 (0.52%)  25/552 (4.53%)  4/574 (0.70%) 
Musculoskeletal and connective tissue disorders         
muscle spasms  1  12/596 (2.01%)  14/580 (2.41%)  13/552 (2.36%)  18/574 (3.14%) 
Nervous system disorders         
dizziness  1  29/596 (4.87%)  58/580 (10.00%)  17/552 (3.08%)  57/574 (9.93%) 
headache  1  42/596 (7.05%)  38/580 (6.55%)  33/552 (5.98%)  37/574 (6.45%) 
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.
Study site may not publish results of study until after coordinated multicenter publication has been submitted for publication or one year after study has ended, whichever occurs first. Therefore, study site will have the opportunity to publish results of study, provided that Daiichi Sankyo has had the opportunity to review and comment on study site’s proposed publication prior to being submitted for publication with advice of company patent council and in accord with subject protection needs.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Howard Kessler
Organization: Daiichi Sankyo
Phone: 732-590-5032
EMail: hmkessler@dsi.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Executive Director Clinical Development, Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00649389     History of Changes
Other Study ID Numbers: CS8635-A-U301
First Submitted: March 28, 2008
First Posted: April 1, 2008
Results First Submitted: August 9, 2010
Results First Posted: September 1, 2010
Last Update Posted: January 9, 2019