| Primary | 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. | 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. | 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. | Posted | | Number | | Percentage of participants | | Baseline to ≤20 weeks | | | | ID | Title | Description |
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| OG000 | Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | 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. |
| | | Title | Denominators | Categories |
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| Overall N=691 | | | | OLM 20 mg N=688 | | | | OLM 20 mg+HCTZ 12.5 mg N=580 | | |
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| Secondary | 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 | 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. | 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. | Posted | | Number | | Percentage of participants | | Baseline to ≤20 weeks | | | | ID | Title | Description |
|---|
| OG000 | Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | 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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| Secondary | 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. | 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. | 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. | Posted | | Number | | Percentage of participants | | Baseline to ≤20 weeks | | | | ID | Title | Description |
|---|
| OG000 | Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | 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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| Secondary | 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 | 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 | 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. | Posted | | Number | | Percentage of Participants | | Baseline to ≤20 weeks | | | | ID | Title | Description |
|---|
| OG000 | Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | 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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| Secondary | Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment | | 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. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to ≤20 weeks | | | | ID | Title | Description |
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| OG000 | Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | 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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| Secondary | Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment | | 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. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to ≤20 weeks | | | | ID | Title | Description |
|---|
| OG000 | Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed | 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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