Trial Outcomes & Findings for Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension (NCT NCT00311155)
NCT ID: NCT00311155
Last Updated: 2010-12-10
Results Overview
For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - \<130 mm Hg; Diastolic - \<80 mm Hg.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
694 participants
Primary outcome timeframe
Baseline to ≤20 weeks
Results posted on
2010-12-10
Participant Flow
The trial was conducted between April 2006 and April 2008 in 9 European countries at 58 investigational sites. The countries participating were: Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Switzerland, and United Kingdom.
Participant milestones
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
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|---|---|
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Overall Study
STARTED
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694
|
|
Overall Study
COMPLETED
|
601
|
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Overall Study
NOT COMPLETED
|
93
|
Reasons for withdrawal
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
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|---|---|
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Overall Study
Adverse Event
|
21
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Overall Study
Withdrawal by Subject
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17
|
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Overall Study
Did not meet entry criteria
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55
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Baseline Characteristics
Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension
Baseline characteristics by cohort
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
n=694 Participants
Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
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|---|---|
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Age Continuous
|
58.16 years
STANDARD_DEVIATION 12.06 • n=5 Participants
|
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Sex: Female, Male
Female
|
337 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
357 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
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12 participants
n=5 Participants
|
|
Region of Enrollment
France
|
121 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
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94 participants
n=5 Participants
|
|
Region of Enrollment
Austria
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35 participants
n=5 Participants
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Region of Enrollment
Netherlands
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43 participants
n=5 Participants
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Region of Enrollment
Germany
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207 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
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141 participants
n=5 Participants
|
|
Region of Enrollment
Italy
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35 participants
n=5 Participants
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Region of Enrollment
Switzerland
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6 participants
n=5 Participants
|
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Weight
|
82.16 kg
STANDARD_DEVIATION 16.09 • n=5 Participants
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Body Mass Index
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28.86 kg/m^2
STANDARD_DEVIATION 4.69 • n=5 Participants
|
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Ethnicity
Caucasian
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678 Participants
n=5 Participants
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|
Ethnicity
Black
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13 Participants
n=5 Participants
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Ethnicity
Asian
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline to ≤20 weeksPopulation: 691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - \<130 mm Hg; Diastolic - \<80 mm Hg.
Outcome measures
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
n=691 Participants
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
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|---|---|
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The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
Overall N=691
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71.8 Percentage of participants
|
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The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
OLM 20 mg N=688
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12.3 Percentage of participants
|
|
The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
OLM 20 mg+HCTZ 12.5 mg N=580
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16.4 Percentage of participants
|
|
The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
OLM 20 mg+HCTZ 25 mg N=446
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19.2 Percentage of participants
|
|
The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
OLM 20 mg+HCTZ 25 mg+AML 5 mg N=296
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14.9 Percentage of participants
|
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The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.
OLM 20 mg+HCTZ 25 mg+AML 10 mg N=176
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8.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to ≤20 weeksPopulation: 691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of \<140 mmHg and mean sitting diastolic blood pressure (dBP)of \<90 mmHg for non-diabetic patients or a mean sitting sBP at trough of \<130 mmHg and mean sitting dBP \<80 mmHg for diabetic patients.
Outcome measures
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
n=691 Participants
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
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|---|---|
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Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Overall N=691
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84.5 Percentage of participants
|
|
Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg N=688
|
22.7 Percentage of participants
|
|
Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg + HCTZ 12.5 mg N=580
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31.1 Percentage of participants
|
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Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg + HCTZ 25 mg N=446
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32.7 Percentage of participants
|
|
Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296
|
23.9 Percentage of participants
|
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Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
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14.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to ≤20 weeksPopulation: 691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.
Outcome measures
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
n=691 Participants
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
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|---|---|
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Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
Overall N=691
|
93.3 Percentage of participants
|
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Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
OLM 20 mg N=688
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36.6 Percentage of participants
|
|
Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
OLM 20 mg + HCTZ 12.5 mg N=580
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52.4 Percentage of participants
|
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Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
OLM 20 mg + HCTZ 25 mg N=446
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48.6 Percentage of participants
|
|
Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296
|
33.4 Percentage of participants
|
|
Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
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20.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to ≤20 weeksPopulation: 691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough
Outcome measures
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
n=691 Participants
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
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|---|---|
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Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
Overall N=691
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92.6 Percentage of Participants
|
|
Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg N=688
|
34.2 Percentage of Participants
|
|
Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg + HCTZ 12.5 mg N=580
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49.6 Percentage of Participants
|
|
Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg + HCTZ 25 mg N=446
|
46.6 Percentage of Participants
|
|
Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296
|
33.3 Percentage of Participants
|
|
Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
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20.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to ≤20 weeksPopulation: 691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Outcome measures
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
n=691 Participants
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
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|---|---|
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Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Overall N=691
|
-15.73 mm Hg
Standard Deviation 7.98
|
|
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg N=688
|
-6.44 mm Hg
Standard Deviation 7.53
|
|
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg + HCTZ 12.5 mg N=580
|
-10.15 mm Hg
Standard Deviation 7.54
|
|
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg + HCTZ 25 mg N=446
|
-13.04 mm Hg
Standard Deviation 7.67
|
|
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296
|
-14.03 mm Hg
Standard Deviation 8.27
|
|
Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
|
-14.47 mm Hg
Standard Deviation 8.86
|
SECONDARY outcome
Timeframe: Baseline to ≤20 weeksPopulation: 691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.
Outcome measures
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
n=691 Participants
Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
|
|---|---|
|
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
Overall N=691
|
-29.58 mm Hg
Standard Deviation 13.52
|
|
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg N=688
|
-11.97 mm Hg
Standard Deviation 11.42
|
|
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg + HCTZ 12.5 mg N=580
|
-19.55 mm Hg
Standard Deviation 12.12
|
|
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg + HCTZ 25 mg N=446
|
-24.51 mm Hg
Standard Deviation 13.14
|
|
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg + HCTZ 25 mg + AML 5 mg N=296
|
-27.06 mm Hg
Standard Deviation 13.72
|
|
Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment
OLM 20 mg + HCTZ 25 mg + AML 10 mg N=176
|
-28.02 mm Hg
Standard Deviation 13.52
|
Adverse Events
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
Serious events: 7 serious events
Other events: 293 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
n=694 participants at risk
Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
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|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.14%
1/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Infections and infestations
Cellulitis
|
0.14%
1/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.14%
1/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Cardiac disorders
Myocardial infacrtion
|
0.14%
1/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.14%
1/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.14%
1/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.14%
1/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
Other adverse events
| Measure |
Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed
n=694 participants at risk
Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
|
|---|---|
|
Infections and infestations
bronchitis
|
6.6%
46/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Infections and infestations
Urinary tract infection
|
3.7%
26/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
17/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
17/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Nervous system disorders
Dizziness
|
11.1%
77/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Nervous system disorders
Headache
|
3.3%
23/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
2.2%
15/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
25/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
15/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
|
General disorders
Oedema peripheral
|
4.6%
32/694 • The time frame was from baseline to up to 20 weeks of treatment
Safety was addressed in terms of occurrences of adverse envents (AEs), of treatment-emergent AEs, changes in vital signs, ECGs, physical examination findings and laboratory parameters. AEs were documented during the whole study period by spontaneous reports to the investigator or upon questioning by or observations by the investigator.
|
Additional Information
Sr. Director, Regulatory Operations
Daiichi Sankyo Pharma Development
Phone: 732-590-5032
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place