| Primary | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | Overall mean reduction from a common mean baseline in SBP | Full analysis set (FAS) included all randomised patients who had at least one seated trough cuff SBP following administration of study drug. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-47.5± 0.69
- OG001-36.9± 0.96
- OG002-43.2± 0.95
|
|
| | 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 |
|---|
| | Repeated measures ANCOVA | | <0.0001 | | Mean Difference (Final Values) | -10.6 | Standard Error of the Mean | 1.18 | 2-Sided | 95 | -12.9 | -8.3 | | | Difference calculated as T80+A10 minus Telmisartan 80 mg | No | Superiority or Other | | | | | Repeated measures ANCOVA |
|
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | Overall mean reduction from a common mean baseline in SBP | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 6 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | Overall mean reduction from a common mean baseline in SBP | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 | Overall mean reduction from a common mean baseline in SBP | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 | Overall mean reduction from a common mean baseline in SBP | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 | Overall mean reduction from a common mean baseline in DBP | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 | Overall mean reduction from a common mean baseline in DBP | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 6 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 | Overall mean reduction from a common mean baseline in DBP | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 | Overall mean reduction from a common mean baseline in DBP | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 | Overall mean reduction from a common mean baseline in DBP | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | Posted | | Least Squares Mean | Standard Error | mmHg (millimeters of mercury) | | baseline and week 1 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Control at Week 1 | Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg | Full analysis set, imputation method used was last observation carried forward (LOCF). | Posted | | Number | | participants | | week 1 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Control at Week 2 | | | Posted | | Number | | participants | | week 2 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Patients Achieving Blood Pressure Control at Week 1 | Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg | | Posted | | Number | | participants | | week 1 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Patients Achieving Blood Pressure Control at Week 2 | SBP < 140 mmHg and DBP < 90 mmHg | | Posted | | Number | | participants | | week 2 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Response at Week 1 | Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg | | Posted | | Number | | participants | | baseline, week 1 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Response at Week 2 | DBP < 90 mmHg or reduction of >= 10 mmHg | | Posted | | Number | | participants | | baseline, week 2 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Patients Achieving Systolic Blood Pressure Response at Week 1 | Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg | | Posted | | Number | | participants | | baseline, week 1 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Patients Achieving Systolic Blood Pressure Response at Week 2 | SBP < 140 mmHg or reduction of >= 15 mmHg | | Posted | | Number | | participants | | baseline, week 2 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | | Posted | | Number | | participants | | week 1 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | | Posted | | Number | | participants | | week 2 | | | | ID | Title | Description |
|---|
| OG000 | T80+A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 5 mg | Amlodipine 5 mg once daily (A5) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Control at Week 4 | | | Posted | | Number | | participants | | week 4 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Control at Week 6 | | | Posted | | Number | | participants | | week 6 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Control at Week 8 | | | Posted | | Number | | participants | | week 8 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Blood Pressure Control at Week 4 | SBP < 140 mmHg and DBP < 90 mmHg | | Posted | | Number | | participants | | week 4 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Blood Pressure Control at Week 6 | SBP < 140 mmHg and DBP < 90 mmHg | | Posted | | Number | | participants | | week 6 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Blood Pressure Control at Week 8 | SBP < 140 mmHg and DBP < 90 mmHg | | Posted | | Number | | participants | | week 8 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Response at Week 4 | DBP < 90 mmHg or reduction of >= 10 mmHg | | Posted | | Number | | participants | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Response at Week 6 | DBP < 90 mmHg or reduction of >= 10 mmHg | | Posted | | Number | | participants | | baseline, week 6 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Diastolic Blood Pressure Response at Week 8 | DBP < 90 mmHg or reduction of >= 10 mmHg | | Posted | | Number | | participants | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Systolic Blood Pressure Response at Week 4 | SBP < 140 mmHg or reduction of >= 15 mmHg | | Posted | | Number | | participants | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Systolic Blood Pressure Response at Week 6 | SBP < 140 mmHg or reduction of >= 15 mmHg | | Posted | | Number | | participants | | baseline, week 6 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Systolic Blood Pressure Response at Week 8 | SBP < 140 mmHg or reduction of >= 15 mmHg | | Posted | | Number | | participants | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Normal Blood Pressure Response at Week 4 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | | Posted | | Number | | participants | | week 4 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Normal Blood Pressure Response at Week 6 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | | Posted | | Number | | participants | | week 6 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |
| Secondary | Patients Achieving Normal Blood Pressure Response at Week 8 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | | Posted | | Number | | participants | | week 8 | | | | ID | Title | Description |
|---|
| OG000 | T80+A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | | OG001 | Telmisartan 80 mg | Telmisartan 80 mg once daily (T80) | | OG002 | Amlodipine 10 mg | Amlodipine 10 mg once daily (A10) |
| |