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Trial record 46 of 134 for:    OLMESARTAN

Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in Hypertension

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ClinicalTrials.gov Identifier: NCT00902538
Recruitment Status : Completed
First Posted : May 15, 2009
Results First Posted : November 22, 2011
Last Update Posted : January 11, 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 40 mg - Amlodipine 10 mg
Drug: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg
Drug: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg
Drug: OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg
Drug: OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg
Enrollment 2204
Recruitment Details First participant visit was 29 April 2009. The last participant follow up was 07 September 2010
Pre-assignment Details The number of subjects entering Period 2 was only 808 because 1278 did not meet the entry criteria.
Arm/Group Title Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25 OLM 40-AML 10-HCTZ 12.5 (Responders) OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders) OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)
Hide Arm/Group Description The participants in this arm received Olmesartan(OLM) 40 mg-Amlodipine(AML) 10 mg oral tablets, once a day, for the 8-week, single-blind, run-in Period 1. Then in Period 2, participants would be randomized to this same combination or have hydrochlorothiazide oral tablets (12.5 or 25 mg) added for an additional 8 weeks. All medication is given once a day. Participants could start receiving OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets given once daily in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3. Participants could start receiving OLM 40-AML 10-HCTZ 25 oral tablets, given once daily, in randomized, double-blind, 8- week Period 2. Participants who meet their blood pressure goals (responded) in Period 3 and continued into 8-week, double-blind Period 4 continued to receive OLM 40-AML 10-HCTZ 12.5 oral tablets given once daily. Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets, given once daily, in double-blind, randomized, Period 4. Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 oral tablets, given once daily, in double-blind, randomized, Period 4
Period Title: 1-Single-blind, Run-in, Single-Treatment
Started 2204 0 0 0 0 0
Completed 2086 0 0 0 0 0
Not Completed 118 0 0 0 0 0
Reason Not Completed
Adverse Event             49             0             0             0             0             0
Withdrawal by Subject             30             0             0             0             0             0
Protocol Violation             22             0             0             0             0             0
Other Reason             13             0             0             0             0             0
Lost to Follow-up             4             0             0             0             0             0
Period Title: 2-Randomized Double-blind 3 Treatments
Started 269 [1] 269 270 0 0 0
Completed 260 263 262 0 0 0
Not Completed 9 6 8 0 0 0
Reason Not Completed
Adverse Event             4             2             3             0             0             0
Withdrawal by Subject             1             2             1             0             0             0
Lost to Follow-up             1             0             2             0             0             0
Other             2             1             0             0             0             0
Protocol Violation             1             1             2             0             0             0
[1]
Only 808 began Period 2 because the others finishing Period 1 did not meet the entry criteria.
Period Title: 3-Single-blind, Single Treatment
Started 0 782 [1] 0 0 0 0
Completed 0 767 0 0 0 0
Not Completed 0 15 0 0 0 0
Reason Not Completed
Adverse Event             0             5             0             0             0             0
Protocol Violation             0             5             0             0             0             0
Withdrawal by Subject             0             4             0             0             0             0
Lost to Follow-up             0             1             0             0             0             0
[1]
Number starting is < total completing previous arm since 3 subjects did not receive at least 1 dose.
Period Title: 4-Randomized Double-blind 2 Treatments
Started 0 0 0 467 [1] 97 [2] 197
Completed 0 0 0 458 95 196
Not Completed 0 0 0 9 2 1
Reason Not Completed
Adverse Event             0             0             0             3             1             1
Withdrawal by Subject             0             0             0             3             1             0
Protocol Violation             0             0             0             3             0             0
[1]
Period 3 responders were continued on OLM 40-AML 10-HCTZ 12.5
[2]
Period 3 non-responders were randomized to OLM 40-AML 10-HCTZ 12.5 or 25 in a 2:1 ratio
Arm/Group Title Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25 Total
Hide Arm/Group Description The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2. Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3 Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. Total of all reporting groups
Overall Number of Baseline Participants 269 269 270 808
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 269 participants 269 participants 270 participants 808 participants
55.9  (10.56) 56.5  (10.25) 54.9  (10.44) 55.8  (10.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 269 participants 269 participants 270 participants 808 participants
Female
119
  44.2%
104
  38.7%
116
  43.0%
339
  42.0%
Male
150
  55.8%
165
  61.3%
154
  57.0%
469
  58.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 269 participants 269 participants 270 participants 808 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   0.4%
1
   0.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
269
 100.0%
269
 100.0%
269
  99.6%
807
  99.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 269 participants 269 participants 270 participants 808 participants
87.8  (18.14) 88.2  (16.03) 88.5  (16.28) 88.2  (16.83)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 269 participants 269 participants 270 participants 808 participants
169.9  (9.74) 170.5  (9.11) 170.4  (8.98) 170.3  (9.27)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 269 participants 269 participants 270 participants 808 participants
30.27  (4.90) 30.30  (4.65) 30.44  (4.87) 30.34  (4.80)
Obesity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 269 participants 269 participants 270 participants 808 participants
Body Mass Index < 30 kg/m^2 138 142 133 413
Body Mass Index >= 30 kg/m^2 131 125 137 393
[1]
Measure Description: Number of participants whose Body Mass Index (BMI) is <30 kg/m^2 or whose number is >=30 kg/m^2. Only 806 participants had their BMI measured.
1.Primary Outcome
Title Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
Hide Description Three cuff blood pressure measurements were taken at each visit.
Time Frame baseline (8 weeks) to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Arm/Group Title Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Hide Arm/Group Description:
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
Overall Number of Participants Analyzed 269 268 269
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-6.1  (0.55) -7.1  (0.55) -8.9  (0.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg, OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1187
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg, OLM 40-AML 10-HCTZ 25
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]
2.Secondary Outcome
Title Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg
Hide Description Three cuff blood pressure measurements were taken at each visit.
Time Frame baseline (8 weeks) to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Arm/Group Title Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Hide Arm/Group Description:
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
Overall Number of Participants Analyzed 269 268 269
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-6.9  (0.76) -8.6  (0.77) -10.5  (0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg, OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0425
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg, OLM 40-AML 10-HCTZ 25
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]
3.Secondary Outcome
Title Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.
Hide Description Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.
Time Frame baseline (week 8) to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Arm/Group Title Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Hide Arm/Group Description:
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
Overall Number of Participants Analyzed 269 268 269
Measure Type: Number
Unit of Measure: Participants
65 79 111
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg, OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1939
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(OLM) 40 Mg-Amlodipine(AML) 10 mg, OLM 40-AML 10-HCTZ 25
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).
Hide Description Three cuff blood pressure measurements were taken at each visit.
Time Frame Baseline (8 weeks) to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Arm/Group Title Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Hide Arm/Group Description:
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
Overall Number of Participants Analyzed 269 268 269
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-2.1  (0.52) -4.0  (0.52) -5.3  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg, OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg, OLM 40-AML 10-HCTZ 25
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]
5.Secondary Outcome
Title Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
Hide Description Three cuff blood pressure measurements were taken at each visit.
Time Frame Baseline (8 weeks) to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.
Arm/Group Title Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Hide Arm/Group Description:
The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
Overall Number of Participants Analyzed 269 268 269
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-1.9  (0.75) -5.1  (0.75) -6.6  (0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg
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 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg, OLM 40-AML 10-HCTZ 25
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]
6.Secondary Outcome
Title In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
Hide Description Change in seated diastolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.
Time Frame week 24 to week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
Arm/Group Title OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders) OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)
Hide Arm/Group Description:
Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
Overall Number of Participants Analyzed 96 196
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-6.7  (0.84) -7.9  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders), OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1611
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
Hide Description Change in seated systolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.
Time Frame week 24 to week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
Arm/Group Title OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders) OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)
Hide Arm/Group Description:
Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
Overall Number of Participants Analyzed 96 196
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-5.5  (1.10) -7.8  (0.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders), OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0451
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.
Hide Description The number of non-responding participants who achieved their blood pressure goals at the end of Period 4. Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.
Time Frame week 24 to week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
Arm/Group Title OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders) OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)
Hide Arm/Group Description:
Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
Overall Number of Participants Analyzed 96 196
Measure Type: Number
Unit of Measure: Participants
31 89
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders), OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0412
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
Hide Description In non-responders, the change in 24-hour diastolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.
Time Frame Week 16 to week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
Arm/Group Title OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Hide Arm/Group Description:
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
Overall Number of Participants Analyzed 96 196
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-2.2  (0.96) -4.4  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5, OLM 40-AML 10-HCTZ 25
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0253
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.
Hide Description In non-responders, the change in 24-hour systolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.
Time Frame Week 16 to week 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.
Arm/Group Title OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Hide Arm/Group Description:
Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
Overall Number of Participants Analyzed 96 196
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-0.4  (1.44) -4.3  (1.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5, OLM 40-AML 10-HCTZ 25
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Adverse events were collected from screening to 14 days after the last dose of study medication. Adverse events are reported for week 1 through week 16.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Hide Arm/Group Description The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2. Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3. Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
All-Cause Mortality
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/2204 (0.82%)      15/269 (5.58%)      3/270 (1.11%)    
Cardiac disorders       
Atrial flbrillation  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 1/270 (0.37%)  1
Atrial flutter  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Cardiac failure  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Cardio-respiratory arrest  1  0/2204 (0.00%)  0 0/269 (0.00%)  0 1/270 (0.37%)  1
Intracardiac thrombus  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Myocardial infarction  1  1/2204 (0.05%)  1 1/269 (0.37%)  1 0/270 (0.00%)  0
Gastrointestinal disorders       
Erosive oesophagitis  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Pancreatitis chronic  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Infections and infestations       
Lobar pneumonia  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Injury, poisoning and procedural complications       
Foot fracture  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Wrist fracture  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Metabolism and nutrition disorders       
Ankle fracture  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Hyperuricaemia  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Osteoarthritis  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Osteochondrosis  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Pseudarthrosis  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Pseudoathrosis  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Polycythaemia vera  1  0/2204 (0.00%)  0 0/269 (0.00%)  0 1/270 (0.37%)  1
Prostate cancer  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Tonsil cancer  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Uterine leiomyoma  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Nervous system disorders       
Cerebral infarction  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Sciatica  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Spinal claudication  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Transient ischaemic attack  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Psychiatric disorders       
Mental disorder  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Transient ischemic attack  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Renal and urinary disorders       
Renal failure  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Status asthmaticus  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Vascular disorders       
Hypertensive crisis  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
Peripheral aterial occlusive disease  1  0/2204 (0.00%)  0 1/269 (0.37%)  1 0/270 (0.00%)  0
Thrombophelibitis  1  1/2204 (0.05%)  1 0/269 (0.00%)  0 0/270 (0.00%)  0
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(OLM) 40 Mg-Amlodipine(AML) 10 mg OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 OLM 40-AML 10-HCTZ 25
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   113/2204 (5.13%)      7/269 (2.60%)      7/270 (2.59%)    
General disorders       
Oedema peripheral  1  113/2204 (5.13%)  113 7/269 (2.60%)  7 7/270 (2.59%)  7
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 multi-center 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 Daiichi Sankyo Europe 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: 0049 89 7808 0 ext 585
EMail: bettina.ammentorp@daiichi-sankyo.eu
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00902538     History of Changes
Other Study ID Numbers: CS8635-A-E303
First Submitted: May 13, 2009
First Posted: May 15, 2009
Results First Submitted: September 6, 2011
Results First Posted: November 22, 2011
Last Update Posted: January 11, 2019