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Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension

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ClinicalTrials.gov Identifier: NCT00923091
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : April 6, 2012
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Essential Hypertension
Interventions Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo
Drug: Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo
Drug: olmesartan medoxomil + amlodipine + hydroclororthiazide
Drug: olmesartan medoxomil + amlodipine
Enrollment 2689
Recruitment Details This study was conduct in Europe from 27 May 2009 to 12 January 2011
Pre-assignment Details Study has randomised, double-blind, placebo-controlled parallel-group portion (Periods I–II) followed by transition phase (Periods III–V) wherein combination titration steps were evaluated in subjects not achieving blood pressure goals. The transition required that all be entered into Period 3 on olm/aml/hctz 20/5/12.5 to ensure a common baseline.
Arm/Group Title Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide(HCT) 40mg/10mg/25mg Olmesartan(OM)20mg/Amlodipine (AML)5mg Olmesartan/Amlodipine 40mg/5mg Olmesartan/Amlodipine 40mg/10mg OM/AML/HCT 40/5/12.5mg Responder Continued on 40/5/12.5 mg OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/12.5mg OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/25mg OM/AML/HCT 20/5/12.5mg NonResponder Up Titrated to 40/5/12.5mg 20/5/12.5mg Responder Continued on 20/5/12.5 mg
Hide Arm/Group Description Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period III, all participants were included in this group. Responders (a participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease) in Period III went directly to Period VI. In Period IV participants who did not meet the blood pressure goals in Period III were randomized in a 1:2 fashion to this group or the OLM/AML/HCTZ 40/5/12.5 group. Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period IV participants who did not meet the blood pressure goals (<140/90 mm Hg; or <130/80 for participants with diabetes or chronic renal or cardiovascular disease)in Period III were randomized in a 1:2 fashion to OLM/AML/HCTZ 20/5/12.5 or this group. Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period V responders continued on olmesartan/amlodipine/ hydrochlorothiazide 40mg/5mg/12.5 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease. In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease. In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease. In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg were up titrated to 40mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease. In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg continued on 20mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
Period Title: PeriodI-II (Randomized, Double-Blind)
Started 335 336 336 336 336 337 337 336 0 0 0 0 0
Completed 319 325 323 309 315 322 319 311 0 0 0 0 0
Not Completed 16 11 13 27 21 15 18 25 0 0 0 0 0
Reason Not Completed
Adverse Event             11             3             7             13             10             5             9             17             0             0             0             0             0
Withdrawal by Subject             4             6             5             8             7             6             5             5             0             0             0             0             0
Protocol Violation             1             1             1             5             4             2             4             3             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             1             0             0             0             0             0             0             0
Other Reason             0             1             0             1             0             1             0             0             0             0             0             0             0
Period Title: Period III (Single-Blind)
Started 2540 [1] 0 0 0 0 0 0 0 0 0 0 0 0
Completed 2520 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 20 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             5             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             10             0             0             0             0             0             0             0             0             0             0             0             0
Protocol Violation             3             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             2             0             0             0             0             0             0             0             0             0             0             0             0
[1]
2543 completed Period 2. Three decided not to continue in the study=2540.
Period Title: Period IV (Double-Blind)
Started 228 [1] 453 0 0 0 0 0 0 0 0 0 0 0
Completed 226 451 0 0 0 0 0 0 0 0 0 0 0
Not Completed 2 2 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             2             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             1             0             0             0             0             0             0             0             0             0             0             0
Protocol Violation             0             1             0             0             0             0             0             0             0             0             0             0             0
[1]
2 did not continue in the study and 1837 responders went directly to Period VI. 228+453+2+1837=2520
Period Title: Period V (Double -Blind)
Started 0 [1] 0 0 0 0 0 0 0 135 119 194 151 75
Completed 0 0 0 0 0 0 0 0 134 119 193 151 73
Not Completed 0 0 0 0 0 0 0 0 1 0 1 0 2
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             0             1             0             0             0             1
Protocol Violation             0             0             0             0             0             0             0             0             0             0             0             0             1
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             1             0             0
[1]
677 completed Period 4. 1 did not continue and 2 erroneously responders were not counted = 674
Period Title: Period VI (Open-Label)
Started 1447 [1] 272 480 146 164 0 0 0 0 0 0 0 0
Completed 1408 264 467 143 157 0 0 0 0 0 0 0 0
Not Completed 39 8 13 3 7 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             17             0             4             1             1             0             0             0             0             0             0             0             0
Withdrawal by Subject             15             7             5             0             1             0             0             0             0             0             0             0             0
Protocol Violation             6             1             3             1             4             0             0             0             0             0             0             0             0
Lost to Follow-up             1             0             1             0             0             0             0             0             0             0             0             0             0
Other Reason             0             0             0             1             1             0             0             0             0             0             0             0             0
[1]
1837 from Period III+2 from Period IV + 670 from Period 5 = 2509
Arm/Group Title Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg Olmesartan/Amlodipine 20mg/5mg Olmesartan/Amlodipine 40mg/5mg Olmesartan/Amlodipine 40mg/10mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 335 336 336 336 336 337 337 336 2689
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 335 participants 336 participants 336 participants 336 participants 336 participants 337 participants 337 participants 336 participants 2689 participants
56.0  (10.81) 56.8  (10.36) 56.5  (10.92) 57.0  (10.72) 55.9  (11.08) 56.1  (10.22) 56.4  (10.4) 57.0  (9.70) 56.5  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 335 participants 336 participants 336 participants 336 participants 336 participants 337 participants 337 participants 336 participants 2689 participants
Female
182
  54.3%
171
  50.9%
184
  54.8%
181
  53.9%
178
  53.0%
185
  54.9%
170
  50.4%
192
  57.1%
1443
  53.7%
Male
153
  45.7%
165
  49.1%
152
  45.2%
155
  46.1%
158
  47.0%
152
  45.1%
167
  49.6%
144
  42.9%
1246
  46.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 335 participants 336 participants 336 participants 336 participants 336 participants 337 participants 337 participants 336 participants 2689 participants
Asian 1 0 1 0 0 0 0 1 3
Black 0 0 0 1 0 0 0 0 1
White 334 336 335 335 336 337 337 335 2685
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Europe Number Analyzed 335 participants 336 participants 336 participants 336 participants 336 participants 337 participants 337 participants 336 participants 2689 participants
335 336 336 336 336 337 337 336 2689
1.Primary Outcome
Title Change in Seated Diastolic Blood Pressure (SeDBP).
Hide Description Baseline blood pressure was defined as the average values obtained at the randomization visit and at the visit prior to randomization
Time Frame Baseline to week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II
Arm/Group Title Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg Olmesartan/Amlodipine 20mg/5mg Olmesartan/Amlodipine 40mg/5mg Olmesartan/Amlodipine 40mg/10mg
Hide Arm/Group Description:
Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
Overall Number of Participants Analyzed 334 336 335 336 332 337 334 335
Least Squares Mean (Standard Error)
Unit of Measure: mm HG
-22.5  (0.48) -22.5  (0.48) -23.0  (0.48) -23.9  (0.47) -23.8  (0.48) -20.5  (0.47) -21.2  (0.48) -22.1  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg, Olmesartan/Amlodipine 20mg/5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0071
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg, Olmesartan/Amlodipine 40mg/5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0323
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg, Olmesartan/Amlodipine 40mg/5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0080
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg, Olmesartan/Amlodipine 40mg/10mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0071
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg, Olmesartan/Amlodipine 40mg/10mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0107
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Seated Systolic Blood Pressure (SeDBP).
Hide Description [Not Specified]
Time Frame Baseline to week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II
Arm/Group Title Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg Olmesartan/Amlodipine 20mg/5mg Olmesartan/Amlodipine 40mg/5mg Olmesartan/Amlodipine 40mg/10mg
Hide Arm/Group Description:
Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
Overall Number of Participants Analyzed 334 336 335 336 332 337 334 335
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-33.2  (0.72) -33.7  (0.72) -35.3  (0.71) -35.5  (0.71) -36.2  (0.72) -29.9  (0.71) -30.4  (0.71) -32.8  (0.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg, Olmesartan/Amlodipine 20mg/5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg, Olmesartan/Amlodipine 40mg/5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg, Olmesartan/Amlodipine 40mg/5mg
Comments [Not Specified]
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 Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg, Olmesartan/Amlodipine 40mg/10mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg, Olmesartan/Amlodipine 40mg/10mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects Reaching Blood Pressure Goal at Week 10
Hide Description Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.
Time Frame baseline to week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II
Arm/Group Title Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg Olmesartan/Amlodipine 20mg/5mg Olmesartan/Amlodipine 40mg/5mg Olmesartan/Amlodipine 40mg/10mg
Hide Arm/Group Description:
Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
Overall Number of Participants Analyzed 334 336 335 336 332 337 334 335
Measure Type: Number
Unit of Measure: Participants
177 176 197 190 179 144 155 166
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg, Olmesartan/Amlodipine 20mg/5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0295
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg, Olmesartan/Amlodipine 40mg/5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2529
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg, Olmesartan/Amlodipine 40mg/5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg, Olmesartan/Amlodipine 40mg/10mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2033
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg, Olmesartan/Amlodipine 40mg/10mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2529
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change in Seated Diastolic Blood Pressure From Week 18 to Week 22
Hide Description [Not Specified]
Time Frame Week 18 to week 22
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV
Arm/Group Title Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg
Hide Arm/Group Description:

Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.

hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5.

Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet.

Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5.

Overall Number of Participants Analyzed 228 453
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-3.3  (0.47) -4.1  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg, Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1135
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in Seated Systolic Blood Pressure From Week 18 to Week 22
Hide Description [Not Specified]
Time Frame Week 18 to week 22
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one blood pressure measurement in Period IV
Arm/Group Title Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg
Hide Arm/Group Description:

Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.

hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5.

Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.

hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5.

Overall Number of Participants Analyzed 228 453
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-5.7  (0.71) -6.5  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg, Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2765
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22
Hide Description Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.
Time Frame Week 18 to week 22
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV
Arm/Group Title Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg
Hide Arm/Group Description:

Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.

hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5.

Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.

hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5.

Overall Number of Participants Analyzed 228 453
Measure Type: Number
Unit of Measure: Participants
63 137
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg, Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4964
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Change in Seated Diastolic Blood Pressure From Week 22 to Week 26
Hide Description [Not Specified]
Time Frame Week 22 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.
Arm/Group Title OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5 OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25
Hide Arm/Group Description:
This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
Overall Number of Participants Analyzed 119 193
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-2.7  (0.68) -3.8  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5, OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1301
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5, OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01301
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change in Seated Systolic Blood Pressure From Week 22 to Week 26
Hide Description [Not Specified]
Time Frame Week 22 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.
Arm/Group Title OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5 OLM/AML/HCTZ40/5/12.5mg Nonresponders Randomized to 40/5/25
Hide Arm/Group Description:
This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
Overall Number of Participants Analyzed 119 193
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-4.5  (1.01) -6.7  (0.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5, OLM/AML/HCTZ40/5/12.5mg Nonresponders Randomized to 40/5/25
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0503
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Number of Subjects Reaching Blood Pressure Goal at Week 26
Hide Description Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.
Time Frame Week 22 to week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V
Arm/Group Title OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5 OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25
Hide Arm/Group Description:
This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
Overall Number of Participants Analyzed 119 193
Measure Type: Number
Unit of Measure: Participants
29 47
10.Secondary Outcome
Title Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25.
Hide Description [Not Specified]
Time Frame Week 26 to week 54
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects up titrated who had blood pressure values at both time points.
Arm/Group Title OLM/AML/HCTZ 40/5/25 Titrated to 40/10/25
Hide Arm/Group Description:
The participants in this arm had their study medication titrated from olmesartan\amlodipine\hydrochlorothiazide 40/5/25 to 40/10/25
Overall Number of Participants Analyzed 87
Mean (Standard Deviation)
Unit of Measure: mm Hg
-11.9  (11.01)
Time Frame Week 1 to week 54
Adverse Event Reporting Description All adverse events, whether observed by the investigator or reported by the participant were recorded on the Adverse Event electronic Case Report Form. Adverse events (AEs)were collected up to 14 days after the last study dose; for serious AEs considered to be drug related there was no time limit.
 
Arm/Group Title Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg Olmesartan/Amlodipine 20mg/5mg Olmesartan/Amlodipine 40mg/5mg Olmesartan/Amlodipine 40mg/10mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg Olmesartan/Amlodipine 20mg/5mg Olmesartan/Amlodipine 40mg/5mg Olmesartan/Amlodipine 40mg/10mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg Olmesartan/Amlodipine 20mg/5mg Olmesartan/Amlodipine 40mg/5mg Olmesartan/Amlodipine 40mg/10mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   55/329 (16.72%)   9/334 (2.69%)   22/331 (6.65%)   3/329 (0.91%)   7/332 (2.11%)   1/333 (0.30%)   5/332 (1.51%)   7/325 (2.15%) 
Cardiac disorders                 
Tachycardia paroxysmal  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  1/332 (0.30%)  0/325 (0.00%) 
Acute myocardial infarction  1  0/329 (0.00%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  1/332 (0.30%)  0/333 (0.00%)  1/332 (0.30%)  0/325 (0.00%) 
Atrial fibrillation  1  2/329 (0.61%)  1/334 (0.30%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  1/325 (0.31%) 
Angina unstable  1  2/329 (0.61%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  1/325 (0.31%) 
Left ventricular failure  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Myocardial infarction  1  1/329 (0.30%)  0/334 (0.00%)  2/331 (0.60%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Cardiogenic shock  1  1/329 (0.30%)  1/334 (0.30%)  1/331 (0.30%)  1/329 (0.30%)  1/332 (0.30%)  1/333 (0.30%)  1/332 (0.30%)  1/325 (0.31%) 
Angina pectoris  1  1/329 (0.30%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Coronary artery disease  1  0/329 (0.00%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Acute coronary syndrome  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  1/329 (0.30%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Extrasystoles  1  0/329 (0.00%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/0  0/325 (0.00%) 
Eye disorders                 
Angle closure glaucoma  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Cataract  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Eye haemorrhage  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Retinal Detachment  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Ulcerative keratitis  1  0/329 (0.00%)  1/334 (0.30%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Gastrointestinal disorders                 
Inguinal hernia  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  1/332 (0.30%)  0/325 (0.00%) 
Oesophagitis  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  1/325 (0.31%) 
Gastric Polyps  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  1/332 (0.30%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Pancreatitis chronic  1  1/329 (0.30%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Colonic polyp  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Gastritis  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Mouth cyst  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Ascites  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Hepatobiliary disorders                 
Cholecystitis  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Infections and infestations                 
Bronchopneumonia  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  1/332 (0.30%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Pneumonia  1  1/329 (0.30%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Sinusitis  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Mediastinitis  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Pyothorax  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Peritonsillar abcess  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Appendicitis  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  1/329 (0.30%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Injury, poisoning and procedural complications                 
Meniscus lesion  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  1/325 (0.31%) 
Tendon rupture  1  2/329 (0.61%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Tibia fracture  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Ankle fracture  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Barotrauma  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Tendon injury  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Intentional overdose  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Patella fracture  1  0/329 (0.00%)  1/334 (0.30%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Vertebral injury  1  0/329 (0.00%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Femeral Neck Fracture  1  0/329 (0.00%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Investigations                 
Electrocardiogram QRS complex shortened  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  1/332 (0.30%)  0/325 (0.00%) 
Hepatitus B virus  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Blood pressure decreased  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Metabolism and nutrition disorders                 
Hypokalemia  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Diabetes mellitus  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Osteoarthritis  1  0/329 (0.00%)  0/334 (0.00%)  4/331 (1.21%)  0/329 (0.00%)  1/332 (0.30%)  0/333 (0.00%)  0/332 (0.00%)  1/325 (0.31%) 
Torticollis  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Back pain  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Musculoskeletal pain  1  0/329 (0.00%)  1/334 (0.30%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Spinal osteoarthritis  1  0/329 (0.00%)  1/334 (0.30%)  0/331 (0.00%)  0/329 (0.00%)  1/332 (0.30%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Breast cancer  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Transitional cell carcinoma  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Ovarian cancer  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Malignant fibrous histiocytoma  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Prostatic adenoma  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Prostate cancer  1  0/329 (0.00%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Uterine leiomyoma  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  1/325 (0.31%) 
Nervous system disorders                 
Transient ischemic attack  1  0/329 (0.00%)  1/334 (0.30%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Ischaemic stroke  1  2/329 (0.61%)  2/334 (0.60%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Syncope  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Dizziness  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Cerebral ischaemia  1  0/329 (0.00%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Psychiatric disorders                 
Completed suicide  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Alcohol abuse  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  1/332 (0.30%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Renal and urinary disorders                 
Calculus ureteric  1  0/329 (0.00%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Hydronephrosis  1  0/329 (0.00%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Reproductive system and breast disorders                 
Uterine polyp  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Benign prostatic hyperplasia  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Prostatitis  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Pulmonary embolism  1  1/329 (0.30%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Surgical and medical procedures                 
Removal of internal fixation  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Vascular disorders                 
Hypertension  1  2/329 (0.61%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Arterial thrombosis limb  1  1/329 (0.30%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
Hypertensive crisis  1  1/329 (0.30%)  0/334 (0.00%)  1/331 (0.30%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  0/332 (0.00%)  0/325 (0.00%) 
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 3%
Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg Olmesartan/Amlodipine 20mg/5mg Olmesartan/Amlodipine 40mg/5mg Olmesartan/Amlodipine 40mg/10mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/329 (3.65%)   44/334 (13.17%)   13/331 (3.93%)   39/329 (11.85%)   45/332 (13.55%)   26/333 (7.81%)   38/332 (11.45%)   30/325 (9.23%) 
General disorders                 
Oedema peripheral  1  0/329 (0.00%)  15/334 (4.49%)  0/331 (0.00%)  26/329 (7.90%)  27/332 (8.13%)  11/333 (3.30%)  16/332 (4.82%)  30/325 (9.23%) 
Investigations                 
Nasopharyngitis  1  0/329 (0.00%)  13/334 (3.89%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  11/332 (3.31%)  0/325 (0.00%) 
Metabolism and nutrition disorders                 
Dyslipidaemia  1  0/329 (0.00%)  0/334 (0.00%)  0/331 (0.00%)  0/329 (0.00%)  0/332 (0.00%)  0/333 (0.00%)  11/332 (3.31%)  0/325 (0.00%) 
Nervous system disorders                 
Headache  1  12/329 (3.65%)  16/334 (4.79%)  13/331 (3.93%)  13/329 (3.95%)  18/332 (5.42%)  15/333 (4.50%)  0/332 (0.00%)  0/325 (0.00%) 
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.
A site may not publish results until after a coordinated multicentre publication has been submitted for publication or until one year after the study has ended, whichever occurs first. Then, the site will have the opportunity to publish the results, provided that DSE has had the opportunity to review and comment on the site’s proposed publication prior to its being submitted for publication with the advice of company patent council and in accord with needs for subject protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bettina Ammentorp
Organization: Daiichi Sankyo Europe, GmbH
Phone: 00498978080
EMail: bettina.ammentorp@daiichi-sankyo.eu
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00923091     History of Changes
Other Study ID Numbers: CS8635-A-E302
First Submitted: June 16, 2009
First Posted: June 18, 2009
Results First Submitted: January 30, 2012
Results First Posted: April 6, 2012
Last Update Posted: January 10, 2019