| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | Posted | | Mean | Standard Deviation | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF)) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 0 mg (T0) | Overall: including Pl, A2.5, A5, and A10 treated groups | | OG001 | Telmisartan 20 mg (T20) | Overall: including all treatment groups involving T20 | | OG002 | Telmisartan 40 mg (T40) | Overall: including all treatment groups involving T40 | | OG003 | Telmisartan 80 mg (T80) | Overall: including all treatment groups involving T80 |
| | Units | Counts |
|---|
| Participants | - OG000355
- OG001171
- OG002440
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-13± 8.8
- OG001-16.4± 7.8
- OG002-16.2± 8.9
- OG003
|
|
| |
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 0 mg (T0) | Overall: including Pl, A2.5, A5, and A10 treated groups | | OG001 | Telmisartan 20 mg (T20) | Overall: including all treatment groups involving T20 | | OG002 | Telmisartan 40 mg (T40) | Overall: including all treatment groups involving T40 | | OG003 | Telmisartan 80 mg (T80) | Overall: including all treatment groups involving T80 |
|
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | Posted | | Mean | Standard Deviation | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning | | OG002 | Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning | | OG003 | Amlodipine 10 mg (A10) | monotherapy (A5 titrated to A10) |
| |
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning | | OG002 | Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning | | OG003 | Amlodipine 10 mg (A10) | monotherapy (A5 titrated to A10) |
|
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | Posted | | Mean | Standard Deviation | mmHg | | End-of-study visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning | | OG004 | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) |
|
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
|
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC), excluding patients treated with placebo | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG001 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG002 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning | | OG003 | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | |
|
| Secondary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
|
| Secondary | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
|
| Secondary | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
|
| Other Pre-specified | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Observed results for key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | Posted | | Mean | Standard Deviation | mmHg | | Baseline to nominal week over the trial | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | DBP Control | DBP control is defined as DBP < 90 mmHg - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | Posted | | Number | | percentage of participants | | End-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | DBP Response | DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | Posted | | Number | | percentage of participants | | End-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | SBP Response | SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | Posted | | Number | | percentage of participants | | End-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Other Pre-specified | BP Control | Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy (FAS-TC). | Posted | | Number | | percentage of participants | | End-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | BP Normality | No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | Posted | | Number | | percentage of participants | | End-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 |
|
| Secondary | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Observed results - key combination therapies | FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy. | Posted | | Mean | Standard Deviation | mmHg | | End-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| |
| Secondary | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Observed results - key combination therapies | FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy. | Posted | | Mean | Standard Deviation | mmHg | | End-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| |
| Secondary | Change From Baseline in ABPM 24-hour Mean DBP | Observed results - key combination therapies | FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy. | Posted | | Mean | Standard Deviation | mmHg | | End-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| |
| Secondary | Change From Baseline in ABPM 24-hour Mean SBP | Observed results - key combination therapies | FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy. | Posted | | Mean | Standard Deviation | mmHg | | End-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| |
| Secondary | Orthostatic Change in Trough Cuff Mean DBP | Calculated as seated minus standing for all patients - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | Posted | | Mean | Standard Deviation | mmHg | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | Orthostatic Change in Trough Cuff Mean SBP | Calculated as seated minus standing for all patients - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | Posted | | Mean | Standard Deviation | mmHg | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect) | | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS). | Posted | | Mean | Standard Deviation | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 0 mg (T0) | Overall: including Pl, A2.5, A5, and A10 treated groups | | OG001 | Telmisartan 20 mg (T20) | Overall: including all treatment groups involving T20 | | OG002 | Telmisartan 40 mg (T40) | Overall: including all treatment groups involving T40 | | OG003 | Telmisartan 80 mg (T80) | Overall: including all treatment groups involving T80 |
| |
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS). | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Amlodipine 2.5 mg (A2.5) | encapsulated Amlodipine 2.5 mg capsule, QD in morning | | OG002 | Amlodipine 5 mg (A5) | encapsulated Amlodipine 5 mg capsule, QD in morning | | OG003 | Amlodipine 10 mg (A10) | |
|
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Mean | Standard Deviation | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine 0 mg (A0) - Overall | Overall: including Pl, T20, T40, and T80 treatment groups | | OG001 | Amlodipine 2.5 mg (A2.5) - Overall | Overall: including all treatment groups involving A2.5 | | OG002 | Amlodipine 5 mg (A5) - Overall | Overall: including all treatment groups involving A5 | | OG003 | Amlodipine 10 mg (A10) - Overall | Overall: including all treatment groups involving A10 |
| |
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Least Squares Mean | Standard Error | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Amlodipine 0 mg (A0) - Overall | Overall: including Pl, T20, T40, and T80 treatment groups | | OG001 | Amlodipine 2.5 mg (A2.5) - Overall | Overall: including all treatment groups involving A2.5 | | OG002 | Amlodipine 5 mg (A5) - Overall | Overall: including all treatment groups involving A5 | | OG003 | Amlodipine 10 mg (A10) - Overall | |
|
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Mean | Standard Deviation | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning | | OG004 |
|
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Least Squares Mean | Standard Error | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
|
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as moderate or severe hypertension at baseline (FAS-TC-MS), excluding patients treated with placebo | Posted | | Least Squares Mean | Standard Error | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG001 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG002 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning | | OG003 | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | |
|
| Secondary | Change From Baseline in Seated Trough Pulse Rate | Observed results for all patients - key combination therapies | The full analysis set relating to the in-clinic trough cuff Pulse Rate measurements included all treated patients that had at least one Pulse Rate measurement following treatment with target therapy (FAS-TC) | Posted | | Mean | Standard Deviation | bpm | | End-of-study visit (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| |
| Secondary | Change From Baseline in Seated Trough Cuff Mean SBP | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Least Squares Mean | Standard Error | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
|
| Secondary | Change From Baseline in Standing Trough Cuff Mean DBP | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Least Squares Mean | Standard Error | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
|
| Other Pre-specified | Change From Baseline in Seated Trough Cuff DBP | Observed results for mod-sev patients - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS). | Posted | | Mean | Standard Deviation | mmHg | | Nominal week over the trial | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tab plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | Change From Baseline in Standing Trough Cuff Mean SBP | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Least Squares Mean | Standard Error | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan 20 mg (T20) | Telmisartan 20mg tablet, QD in morning | | OG002 | Telmisartan 40 mg (T40) | Telmisartan 40mg tablet, QD in morning | | OG003 | Telmisartan 80 mg (T80) | Telmisartan 80mg tablet, QD in morning |
|
| Secondary | DBP Control | DBP control is defined as DBP < 90 mmHg - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Number | | percentage of participants | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | DBP Response | DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Number | | percentage of participants | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Other Pre-specified | BP Control | Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS). | Posted | | Number | | percentage of participants | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tab plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | SBP Response | SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Number | | percentage of participants | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | BP Normality | No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS) | Posted | | Number | | percentage of participants | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tab plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning |
|
| Secondary | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Observed results for mod-sev patients - key combination therapies | FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy. | Posted | | Mean | Standard Deviation | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tab plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| |
| Secondary | Change From Baseline in ABPM 24-hour Mean DBP | Observed results for mod-sev patients - key combination therapies | FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy. | Posted | | Mean | Standard Deviation | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tab plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| |
| Secondary | Change From Baseline in ABPM 24-hour Mean SBP | Observed results for mod-sev patients - key combination therapies | FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy. | Posted | | Mean | Standard Deviation | mmHg | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
| |
| Secondary | Orthostatic Change in Trough Cuff Mean DBP | Calculated as seated minus standing for mod-sev patients - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS). | Posted | | Mean | Standard Deviation | mmHg | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tab plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | Orthostatic Change in Trough Cuff Mean SBP | Calculated as seated minus standing for mod-sev patients - key combination therapies | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS). | Posted | | Mean | Standard Deviation | mmHg | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tab plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | Change From Baseline in Seated Trough Pulse Rate | Observed results for mod-sev patients - key combination therapies | The full analysis set relating to the in-clinic trough pulse rate measurements included all treated patients that had at least one in-clinic pulse rate measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS). | Posted | | Mean | Standard Deviation | bpm | | Up to 8 weeks (LOCF) | | | | ID | Title | Description |
|---|
| OG000 | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | T40mg tab plus encapsulated A5mg capsule, QD in morning | | OG001 | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | T40mg tab plus 2 encapsulated A5mg capsule, QD in morning | | OG002 | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | T80mg tab plus encapsulated A5mg capsule, QD in morning | | OG003 | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | T80mg tab plus 2 encapsulated A5mg capsule, QD in morning |
|
| Secondary | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations). | | Posted | | Number | | percentage of participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo (Pl) | placebo tablet plus encapsulated placebo tablet, QD in morning | | OG001 | Telmisartan Monotherapy | Telmisartan 20/40/80mg tablet, QD in morning | | OG002 | Amlodipine Monotherapy | encapsulated Amlodipine 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning | | OG003 | Combination Therapy | Telmisartan 20/40/80mg tablet plus 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning |
| |