| Primary | Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period. | Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'. | Full analysis set (FAS) was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period | Posted | | Mean | Standard Error | mmHg | | baseline and 8 weeks | | | | ID | Title | Description |
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| OG000 | Telmisartan + HCTZ + Amlodipine | telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) | | OG001 | Telmisartan + HCTZ + Placebo | telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-8.8± 0.8
- OG001-1.3± 0.8
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | LOCF-ANCOVA | Last observation carried forward (LOCF) was used as the imputation method | <0.0001 | | Adjusted mean, comparison | -7.5 | Standard Error of the Mean | 1.1 | 2-Sided | 95 | -9.7 | -5.3 | | | Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects. | No | Superiority or Other | | |
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| Secondary | Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period. | Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'. | | Posted | | Mean | Standard Error | mmHg | | baseline and 8 weeks | | | | ID | Title | Description |
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| OG000 | Telmisartan + HCTZ + Amlodipine | telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) | | OG001 | Telmisartan + HCTZ + Placebo | telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) |
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| Secondary | The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period. | The percentage of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'. | | Posted | | Number | 95% Confidence Interval | Participants | | Double-blind and 8 weeks | | | | ID | Title | Description |
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| OG000 | Telmisartan + HCTZ + Amlodipine | telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) | | OG001 | Telmisartan + HCTZ + Placebo | telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) |
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| Secondary | The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period. | The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'. | | Posted | | Number | | Participants | | Reference baseline (week 0) and week 60 (end of extension period) | | | | ID | Title | Description |
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| OG000 | Telmisartan + HCTZ + Amlodipine | telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) | | OG001 | Telmisartan + HCTZ + Placebo | telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) |
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| Secondary | Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period. | Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'. | FAS in the extension period (FASEX OC) was defined as a collection of patients i) included in the FAS; ii) taking at least 1 dose of T80/A5/H12.5 mg in the extension period; and iii) taking measurements of seated DBP at reference baseline and at 1 or more time points in the extension period. | Posted | | Mean | Standard Error | mmHg | | Reference baseline (week 0) and week 60 (end of extension period) | | | | ID | Title | Description |
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| OG000 | Telmisartan + HCTZ + Amlodipine + Ext | telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) | | OG001 | Telmisartan + HCTZ + Placebo + Ext | telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) |
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| Secondary | Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period. | Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'. | | Posted | | Mean | Standard Error | mmHg | | Reference baseline (week 0) and week 60 (end of extension period) | | | | ID | Title | Description |
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| OG000 | Telmisartan + HCTZ + Amlodipine + Ext | telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) | | OG001 | Telmisartan + HCTZ + Placebo + Ext | telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) |
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