Trial Outcomes & Findings for Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension (NCT NCT00281580)
NCT ID: NCT00281580
Last Updated: 2014-03-27
Results Overview
Observed results
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1461 participants
Primary outcome timeframe
Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))
Results posted on
2014-03-27
Participant Flow
Participant milestones
| Measure |
Placebo (Pl)
placebo tablet plus encapsulated placebo tablet, QD in morning
|
Telmisartan 20 mg (T20)
Telmisartan 20mg tablet, QD in morning
|
Telmisartan 40 mg (T40)
Telmisartan 40mg tablet, QD in morning
|
Telmisartan 80 mg (T80)
Telmisartan 80mg tablet, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
42
|
130
|
135
|
44
|
46
|
44
|
47
|
143
|
129
|
48
|
146
|
142
|
50
|
140
|
129
|
|
Overall Study
COMPLETED
|
39
|
41
|
125
|
118
|
40
|
43
|
39
|
46
|
135
|
117
|
44
|
136
|
129
|
43
|
133
|
116
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
5
|
17
|
4
|
3
|
5
|
1
|
8
|
12
|
4
|
10
|
13
|
7
|
7
|
13
|
Reasons for withdrawal
| Measure |
Placebo (Pl)
placebo tablet plus encapsulated placebo tablet, QD in morning
|
Telmisartan 20 mg (T20)
Telmisartan 20mg tablet, QD in morning
|
Telmisartan 40 mg (T40)
Telmisartan 40mg tablet, QD in morning
|
Telmisartan 80 mg (T80)
Telmisartan 80mg tablet, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
2
|
4
|
1
|
0
|
1
|
0
|
1
|
6
|
0
|
5
|
8
|
2
|
3
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
2
|
0
|
1
|
2
|
0
|
1
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
1
|
1
|
2
|
2
|
0
|
1
|
4
|
1
|
1
|
2
|
2
|
1
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
1
|
6
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
3
|
0
|
1
|
0
|
1
|
2
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Randomised in error; pregnancy; moving
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
2
|
1
|
1
|
1
|
2
|
0
|
1
|
2
|
Baseline Characteristics
Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
Baseline characteristics by cohort
| Measure |
Placebo (Pl)
n=46 Participants
placebo tablet plus encapsulated placebo tablet, QD in morning
|
Telmisartan 20 mg (T20)
n=42 Participants
Telmisartan 20mg tablet, QD in morning
|
Telmisartan 40 mg (T40)
n=130 Participants
Telmisartan 40mg tablet, QD in morning
|
Telmisartan 80 mg (T80)
n=135 Participants
Telmisartan 80mg tablet, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=44 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=46 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=44 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=47 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=143 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=129 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=48 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=146 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=142 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=50 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=140 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=129 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
Total
n=1461 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.5 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
53.6 Years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
52 Years
STANDARD_DEVIATION 11 • n=5 Participants
|
53.1 Years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
54 Years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
54.4 Years
STANDARD_DEVIATION 10.2 • n=10 Participants
|
51 Years
STANDARD_DEVIATION 11.2 • n=115 Participants
|
50.7 Years
STANDARD_DEVIATION 10.2 • n=24 Participants
|
52.3 Years
STANDARD_DEVIATION 11.9 • n=42 Participants
|
53.3 Years
STANDARD_DEVIATION 11.3 • n=42 Participants
|
54.8 Years
STANDARD_DEVIATION 9.7 • n=42 Participants
|
52.7 Years
STANDARD_DEVIATION 11.9 • n=42 Participants
|
53.9 Years
STANDARD_DEVIATION 11.6 • n=36 Participants
|
55.3 Years
STANDARD_DEVIATION 10.4 • n=36 Participants
|
53.1 Years
STANDARD_DEVIATION 10.6 • n=24 Participants
|
53.4 Years
STANDARD_DEVIATION 10.7 • n=135 Participants
|
53.1 Years
STANDARD_DEVIATION 11.1 • n=136 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
21 Participants
n=24 Participants
|
72 Participants
n=42 Participants
|
67 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
72 Participants
n=42 Participants
|
78 Participants
n=36 Participants
|
23 Participants
n=36 Participants
|
68 Participants
n=24 Participants
|
64 Participants
n=135 Participants
|
724 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
71 Participants
n=42 Participants
|
62 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
74 Participants
n=42 Participants
|
64 Participants
n=36 Participants
|
27 Participants
n=36 Participants
|
72 Participants
n=24 Participants
|
65 Participants
n=135 Participants
|
737 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))Population: 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).
Observed results
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=355 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=171 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=440 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=457 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)
|
-13 mmHg
Standard Deviation 8.8
|
-16.4 mmHg
Standard Deviation 7.8
|
-16.2 mmHg
Standard Deviation 8.9
|
-16.9 mmHg
Standard Deviation 8.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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).
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=355 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=171 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=440 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=457 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
|
-12.5 mmHg
Standard Error 0.5
|
-16.8 mmHg
Standard Error 0.6
|
-16.6 mmHg
Standard Error 0.4
|
-17.2 mmHg
Standard Error 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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).
Observed results
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=349 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=185 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=466 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=423 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
|
-12.3 mmHg
Standard Deviation 9.7
|
-14.9 mmHg
Standard Deviation 8.8
|
-15.6 mmHg
Standard Deviation 8.1
|
-18.6 mmHg
Standard Deviation 7.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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).
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=349 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=185 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=466 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=423 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
|
-12.2 mmHg
Standard Error 0.5
|
-15.3 mmHg
Standard Error 0.6
|
-16.2 mmHg
Standard Error 0.4
|
-19.3 mmHg
Standard Error 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End-of-study visit (LOCF)Population: 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).
Observed results
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=46 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=42 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=129 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=132 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=44 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=45 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=40 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=47 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=141 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=123 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=46 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=143 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=136 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=48 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=137 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=124 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
|
-5.9 mmHg
Standard Deviation 9.4
|
-13.2 mmHg
Standard Deviation 9
|
-13.1 mmHg
Standard Deviation 10.1
|
-13.6 mmHg
Standard Deviation 8.7
|
-18 mmHg
Standard Deviation 7.8
|
-15.7 mmHg
Standard Deviation 6.5
|
-18.7 mmHg
Standard Deviation 7
|
-16.2 mmHg
Standard Deviation 8.2
|
-16 mmHg
Standard Deviation 7.6
|
-19.6 mmHg
Standard Deviation 7.9
|
-15.3 mmHg
Standard Deviation 7.5
|
-17.8 mmHg
Standard Deviation 8.5
|
-19.6 mmHg
Standard Deviation 7.9
|
-10.4 mmHg
Standard Deviation 9.9
|
-13 mmHg
Standard Deviation 7.9
|
-16.5 mmHg
Standard Deviation 7.1
|
PRIMARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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).
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=46 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=42 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=129 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=132 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=44 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=45 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=40 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=47 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=141 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=123 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=46 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=143 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=136 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=48 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=137 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=124 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
|
-6.2 mmHg
Standard Error 1.2
|
-13.8 mmHg
Standard Error 1.3
|
-13.4 mmHg
Standard Error 0.7
|
-14 mmHg
Standard Error 0.7
|
-18.3 mmHg
Standard Error 1.2
|
-15.9 mmHg
Standard Error 1.2
|
-19.3 mmHg
Standard Error 1.3
|
-16.9 mmHg
Standard Error 1.2
|
-16.5 mmHg
Standard Error 0.7
|
-20.2 mmHg
Standard Error 0.7
|
-15.7 mmHg
Standard Error 1.2
|
-18.2 mmHg
Standard Error 0.7
|
-20.1 mmHg
Standard Error 0.7
|
-10.6 mmHg
Standard Error 1.2
|
-13.4 mmHg
Standard Error 0.7
|
-17.11 mmHg
Standard Error 0.7
|
PRIMARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=42 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=129 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=132 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=44 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=45 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=40 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=47 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=141 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=123 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=46 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=143 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=136 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=48 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=137 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=124 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
|
-13.8 mmHg
Standard Error 1.2
|
-13.4 mmHg
Standard Error 0.7
|
-14 mmHg
Standard Error 0.7
|
-18.3 mmHg
Standard Error 1.2
|
-15.9 mmHg
Standard Error 1.2
|
-19.3 mmHg
Standard Error 1.3
|
-16.9 mmHg
Standard Error 1.2
|
-16.5 mmHg
Standard Error 0.7
|
-20.2 mmHg
Standard Error 0.7
|
-15.7 mmHg
Standard Error 1.2
|
-18.2 mmHg
Standard Error 0.7
|
-20.1 mmHg
Standard Error 0.7
|
-10.6 mmHg
Standard Error 1.2
|
-13.4 mmHg
Standard Error 0.7
|
-17.1 mmHg
Standard Error 0.7
|
—
|
PRIMARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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).
Observed results
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=256 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=129 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=334 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=331 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)
|
-13.1 mmHg
Standard Deviation 9
|
-16.8 mmHg
Standard Deviation 8
|
-16.9 mmHg
Standard Deviation 8.9
|
-17.7 mmHg
Standard Deviation 8.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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).
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=256 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=129 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=334 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=331 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
|
-12.7 mmHg
Standard Error 0.5
|
-17.3 mmHg
Standard Error 0.7
|
-17.3 mmHg
Standard Error 0.5
|
-18 mmHg
Standard Error 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
Observed results
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=257 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=137 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=349 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=307 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
|
-12.7 mmHg
Standard Deviation 10.1
|
-16 mmHg
Standard Deviation 8.4
|
-16.3 mmHg
Standard Deviation 8.3
|
-19.2 mmHg
Standard Deviation 7.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=257 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=137 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=349 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=307 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
|
-12.5 mmHg
Standard Error 0.5
|
-16.4 mmHg
Standard Error 0.7
|
-16.7 mmHg
Standard Error 0.5
|
-19.7 mmHg
Standard Error 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
Observed results
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=35 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=33 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=100 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=89 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=34 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=34 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=28 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=30 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=108 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=96 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=36 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=106 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=100 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=37 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=101 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=83 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
|
-5.5 mmHg
Standard Deviation 10.1
|
-13.9 mmHg
Standard Deviation 9.4
|
-13.8 mmHg
Standard Deviation 10.2
|
-13.9 mmHg
Standard Deviation 9.2
|
-18.4 mmHg
Standard Deviation 7.9
|
-15.8 mmHg
Standard Deviation 6.4
|
-19.5 mmHg
Standard Deviation 7.2
|
-18.7 mmHg
Standard Deviation 7.9
|
-16.8 mmHg
Standard Deviation 7.5
|
-19.6 mmHg
Standard Deviation 8.3
|
-16.3 mmHg
Standard Deviation 7.7
|
-18.8 mmHg
Standard Deviation 9
|
-20.4 mmHg
Standard Deviation 7.3
|
-11.4 mmHg
Standard Deviation 8.3
|
-13.1 mmHg
Standard Deviation 8.1
|
-17.1 mmHg
Standard Deviation 7.6
|
PRIMARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=35 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=33 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=100 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=89 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=34 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=34 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=28 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=30 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=108 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=96 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=36 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=106 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=100 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=37 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=101 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=83 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
|
-5.8 mmHg
Standard Error 1.4
|
-14.4 mmHg
Standard Error 1.4
|
-14.2 mmHg
Standard Error 0.8
|
-14.1 mmHg
Standard Error 0.9
|
-18.9 mmHg
Standard Error 1.4
|
-15.9 mmHg
Standard Error 1.4
|
-19.7 mmHg
Standard Error 1.6
|
-18.8 mmHg
Standard Error 1.5
|
-17.2 mmHg
Standard Error 0.8
|
-20.1 mmHg
Standard Error 0.8
|
-16.6 mmHg
Standard Error 1.4
|
-19.1 mmHg
Standard Error 0.8
|
-21 mmHg
Standard Error 0.8
|
-11.7 mmHg
Standard Error 1.4
|
-13.3 mmHg
Standard Error 0.8
|
-17.6 mmHg
Standard Error 0.9
|
PRIMARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=33 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=100 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=89 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=34 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=34 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=28 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=30 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=108 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=96 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=36 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=106 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=100 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=37 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=101 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=83 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
|
-14.5 mmHg
Standard Error 1.4
|
-14.2 mmHg
Standard Error 0.8
|
-14.1 mmHg
Standard Error 0.9
|
-18.9 mmHg
Standard Error 1.4
|
-15.9 mmHg
Standard Error 1.4
|
-19.7 mmHg
Standard Error 1.5
|
-18.8 mmHg
Standard Error 1.5
|
-17.2 mmHg
Standard Error 0.8
|
-20.1 mmHg
Standard Error 0.8
|
-16.6 mmHg
Standard Error 1.4
|
-19.1 mmHg
Standard Error 0.8
|
-21 mmHg
Standard Error 0.8
|
-11.7 mmHg
Standard Error 1.3
|
-13.3 mmHg
Standard Error 0.8
|
-17.6 mmHg
Standard Error 0.9
|
—
|
SECONDARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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)
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=46 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=42 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=129 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=132 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=44 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=45 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=40 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=47 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=141 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=123 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=46 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=143 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=136 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=48 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=137 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=124 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)
|
-2.5 mmHg
Standard Error 1.8
|
-15.1 mmHg
Standard Error 1.9
|
-14.6 mmHg
Standard Error 1.1
|
-14.3 mmHg
Standard Error 1.1
|
-18.8 mmHg
Standard Error 1.9
|
-21 mmHg
Standard Error 1.9
|
-24.4 mmHg
Standard Error 2
|
-21.9 mmHg
Standard Error 1.8
|
-21.8 mmHg
Standard Error 1.1
|
-24.7 mmHg
Standard Error 1.1
|
-17.4 mmHg
Standard Error 1.8
|
-22.1 mmHg
Standard Error 1
|
-26.4 mmHg
Standard Error 1.1
|
-11.4 mmHg
Standard Error 1.8
|
-15.4 mmHg
Standard Error 1.1
|
-20.7 mmHg
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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)
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=46 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=42 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=128 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=129 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=44 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=45 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=40 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=47 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=139 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=123 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=46 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=142 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=134 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=46 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=137 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=122 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP
|
-4.9 mmHg
Standard Error 1.2
|
-10.4 mmHg
Standard Error 1.3
|
-10 mmHg
Standard Error 0.8
|
-11.1 mmHg
Standard Error 0.8
|
-14.9 mmHg
Standard Error 1.3
|
-13.1 mmHg
Standard Error 1.3
|
-16.9 mmHg
Standard Error 1.3
|
-15.8 mmHg
Standard Error 1.2
|
-13.6 mmHg
Standard Error 0.7
|
-18.4 mmHg
Standard Error 0.8
|
-13.4 mmHg
Standard Error 1.2
|
-16.2 mmHg
Standard Error 0.7
|
-19 mmHg
Standard Error 0.7
|
-8.1 mmHg
Standard Error 1.2
|
-11.3 mmHg
Standard Error 0.7
|
-14.6 mmHg
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline to end-of-study (up to 8 weeks) visit (LOCF)Population: 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)
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=46 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=42 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=128 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=129 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=44 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=45 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=40 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=47 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=139 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=123 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=46 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=142 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=134 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=46 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=137 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=122 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP
|
-0.5 mmHg
Standard Error 1.9
|
-13.2 mmHg
Standard Error 2
|
-13.2 mmHg
Standard Error 1.1
|
-12.9 mmHg
Standard Error 1.1
|
-17.4 mmHg
Standard Error 1.9
|
-18.9 mmHg
Standard Error 1.9
|
-22.3 mmHg
Standard Error 2
|
-20.3 mmHg
Standard Error 1.8
|
-20 mmHg
Standard Error 1.1
|
-22.8 mmHg
Standard Error 1.1
|
-17.4 mmHg
Standard Error 1.9
|
-21.2 mmHg
Standard Error 1.1
|
-24.9 mmHg
Standard Error 1.1
|
-9.1 mmHg
Standard Error 1.9
|
-14.7 mmHg
Standard Error 1.1
|
-19.1 mmHg
Standard Error 1.2
|
SECONDARY outcome
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)Population: 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)
DBP control is defined as DBP \< 90 mmHg - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=141 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=123 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=143 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=136 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DBP Control
|
71.6 percentage of participants
|
82.1 percentage of participants
|
74.8 percentage of participants
|
85.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)Population: 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)
DBP response is defined as DBP \< 90 mmHg or a reduction of DBP of \>= 10 mmHg - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=141 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=123 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=143 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=136 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DBP Response
|
80.9 percentage of participants
|
91.9 percentage of participants
|
88.8 percentage of participants
|
91.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)Population: 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)
SBP Response is defined as SBP \< 140 mmHg or a reduction of SBP of \>= 10 mmHg - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=139 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=123 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=142 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=134 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SBP Response
|
91.5 percentage of participants
|
96.7 percentage of participants
|
87.4 percentage of participants
|
94.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)Population: 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)
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
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=139 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=123 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=142 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=134 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
BP Normality
Optimal (SBP<120 and DBP<80)
|
9.2 percentage of participants
|
13 percentage of participants
|
9.8 percentage of participants
|
14.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
BP Normality
No (SBP>=140 and/or DBP>=90)
|
41.1 percentage of participants
|
24.4 percentage of participants
|
34.3 percentage of participants
|
23.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
BP Normality
High Normal (140>SBP>=130 and 90>DBP>=85)
|
28.4 percentage of participants
|
30.1 percentage of participants
|
30.1 percentage of participants
|
22.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
BP Normality
Normal (130>SBP>=120 and 85>DBP>=80)
|
21.3 percentage of participants
|
32.5 percentage of participants
|
25.9 percentage of participants
|
39.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)Population: 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.
Observed results - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=57 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=57 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=56 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=52 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 1
|
-10.7 mmHg
Standard Deviation 9.5
|
-15.4 mmHg
Standard Deviation 11.6
|
-12.7 mmHg
Standard Deviation 9.9
|
-13.4 mmHg
Standard Deviation 9.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 2
|
-9.8 mmHg
Standard Deviation 11.7
|
-15 mmHg
Standard Deviation 12.2
|
-13.4 mmHg
Standard Deviation 9.5
|
-14.6 mmHg
Standard Deviation 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 3
|
-11.2 mmHg
Standard Deviation 13.2
|
-14.1 mmHg
Standard Deviation 12.6
|
-14.8 mmHg
Standard Deviation 11.6
|
-15.4 mmHg
Standard Deviation 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 4
|
-11.3 mmHg
Standard Deviation 11.8
|
-16.5 mmHg
Standard Deviation 13.2
|
-15.6 mmHg
Standard Deviation 11.7
|
-15.8 mmHg
Standard Deviation 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 5
|
-13.1 mmHg
Standard Deviation 11
|
-14.1 mmHg
Standard Deviation 14.4
|
-16.3 mmHg
Standard Deviation 14.3
|
-15.7 mmHg
Standard Deviation 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 6
|
-10.9 mmHg
Standard Deviation 11.6
|
-14.5 mmHg
Standard Deviation 12.4
|
-14.6 mmHg
Standard Deviation 9.9
|
-16.4 mmHg
Standard Deviation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 7
|
-12.8 mmHg
Standard Deviation 10.2
|
-15.6 mmHg
Standard Deviation 13.9
|
-12.9 mmHg
Standard Deviation 10.4
|
-15.7 mmHg
Standard Deviation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 8
|
-12.1 mmHg
Standard Deviation 12.3
|
-17.4 mmHg
Standard Deviation 13.6
|
-12.7 mmHg
Standard Deviation 13.6
|
-17.1 mmHg
Standard Deviation 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 9
|
-13.1 mmHg
Standard Deviation 10.3
|
-15.7 mmHg
Standard Deviation 14.4
|
-14.3 mmHg
Standard Deviation 14.3
|
-17.2 mmHg
Standard Deviation 13.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 10
|
-11.8 mmHg
Standard Deviation 10.3
|
-13.8 mmHg
Standard Deviation 13.5
|
-14.7 mmHg
Standard Deviation 15.7
|
-18.5 mmHg
Standard Deviation 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 11
|
-11.2 mmHg
Standard Deviation 12.9
|
-14.4 mmHg
Standard Deviation 11.9
|
-15.1 mmHg
Standard Deviation 13.1
|
-16.1 mmHg
Standard Deviation 12.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 12
|
-12 mmHg
Standard Deviation 11.3
|
-13.3 mmHg
Standard Deviation 12.9
|
-12.5 mmHg
Standard Deviation 14.8
|
-15.7 mmHg
Standard Deviation 12.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 13
|
-10.3 mmHg
Standard Deviation 11.7
|
-14.7 mmHg
Standard Deviation 14.3
|
-14.1 mmHg
Standard Deviation 13.5
|
-15.1 mmHg
Standard Deviation 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 14
|
-8.9 mmHg
Standard Deviation 13.2
|
-14.8 mmHg
Standard Deviation 14.1
|
-13.4 mmHg
Standard Deviation 13.4
|
-11 mmHg
Standard Deviation 14.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 15
|
-10.3 mmHg
Standard Deviation 16
|
-11.5 mmHg
Standard Deviation 14.3
|
-11.9 mmHg
Standard Deviation 14.8
|
-10 mmHg
Standard Deviation 12.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 16
|
-10.1 mmHg
Standard Deviation 15
|
-10.3 mmHg
Standard Deviation 15.4
|
-11.3 mmHg
Standard Deviation 12
|
-12.2 mmHg
Standard Deviation 13.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 17
|
-9.8 mmHg
Standard Deviation 13.7
|
-10.4 mmHg
Standard Deviation 14.4
|
-11.2 mmHg
Standard Deviation 12.5
|
-11.5 mmHg
Standard Deviation 13.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 18
|
-11.9 mmHg
Standard Deviation 15
|
-9.9 mmHg
Standard Deviation 12.4
|
-10.3 mmHg
Standard Deviation 12.3
|
-12.2 mmHg
Standard Deviation 11.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 19
|
-9.1 mmHg
Standard Deviation 10.9
|
-10.5 mmHg
Standard Deviation 13.7
|
-11.9 mmHg
Standard Deviation 10.4
|
-13.2 mmHg
Standard Deviation 11.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 20
|
-11 mmHg
Standard Deviation 11.9
|
-9.9 mmHg
Standard Deviation 12.4
|
-12.6 mmHg
Standard Deviation 11.1
|
-15.9 mmHg
Standard Deviation 11.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 21
|
-10.4 mmHg
Standard Deviation 13
|
-8.9 mmHg
Standard Deviation 13.2
|
-8.5 mmHg
Standard Deviation 12.7
|
-14.8 mmHg
Standard Deviation 9.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 22
|
-11.1 mmHg
Standard Deviation 12.6
|
-9.8 mmHg
Standard Deviation 13.7
|
-9.7 mmHg
Standard Deviation 12.9
|
-15.4 mmHg
Standard Deviation 9.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 23
|
-9.8 mmHg
Standard Deviation 11.3
|
-13.3 mmHg
Standard Deviation 13.4
|
-9.9 mmHg
Standard Deviation 12.2
|
-14.6 mmHg
Standard Deviation 9.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 24
|
-11.1 mmHg
Standard Deviation 9.5
|
-12.6 mmHg
Standard Deviation 11.5
|
-12 mmHg
Standard Deviation 13.1
|
-13.1 mmHg
Standard Deviation 11.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)Population: 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.
Observed results - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=57 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=57 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=56 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=52 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 1
|
-18.7 mmHg
Standard Deviation 12.9
|
-20.2 mmHg
Standard Deviation 16.5
|
-19.1 mmHg
Standard Deviation 13.4
|
-17.5 mmHg
Standard Deviation 15.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 2
|
-13.1 mmHg
Standard Deviation 16.5
|
-22.0 mmHg
Standard Deviation 17.9
|
-20.5 mmHg
Standard Deviation 16.6
|
-21.9 mmHg
Standard Deviation 15.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 3
|
-15.3 mmHg
Standard Deviation 16.1
|
-17.9 mmHg
Standard Deviation 18.9
|
-21.1 mmHg
Standard Deviation 17.8
|
-22.4 mmHg
Standard Deviation 16.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 4
|
-18.0 mmHg
Standard Deviation 16.9
|
-24.4 mmHg
Standard Deviation 20.6
|
-22.5 mmHg
Standard Deviation 16.5
|
-23.8 mmHg
Standard Deviation 15.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 5
|
-19.3 mmHg
Standard Deviation 13.6
|
-21.1 mmHg
Standard Deviation 19.8
|
-25.3 mmHg
Standard Deviation 18.1
|
-24.0 mmHg
Standard Deviation 16.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 6
|
-14.1 mmHg
Standard Deviation 14.0
|
-22.6 mmHg
Standard Deviation 14.9
|
-21.6 mmHg
Standard Deviation 15.9
|
-24.6 mmHg
Standard Deviation 14.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 7
|
-17.8 mmHg
Standard Deviation 14.5
|
-24.3 mmHg
Standard Deviation 19.5
|
-19.9 mmHg
Standard Deviation 17.7
|
-22.4 mmHg
Standard Deviation 15.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 8
|
-18.8 mmHg
Standard Deviation 17.1
|
-24.1 mmHg
Standard Deviation 20.8
|
-20.3 mmHg
Standard Deviation 18.6
|
-21.8 mmHg
Standard Deviation 15.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 9
|
-20.3 mmHg
Standard Deviation 15.6
|
-24.9 mmHg
Standard Deviation 20.0
|
-22.0 mmHg
Standard Deviation 19.2
|
-25.6 mmHg
Standard Deviation 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 10
|
-20.0 mmHg
Standard Deviation 16.0
|
-22.9 mmHg
Standard Deviation 19.2
|
-22.5 mmHg
Standard Deviation 19.3
|
-26.8 mmHg
Standard Deviation 19.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 11
|
-18.7 mmHg
Standard Deviation 17.4
|
-20.9 mmHg
Standard Deviation 19.8
|
-23.2 mmHg
Standard Deviation 16.7
|
-24.9 mmHg
Standard Deviation 15.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 12
|
-18.4 mmHg
Standard Deviation 16.8
|
-20.3 mmHg
Standard Deviation 19.5
|
-19.7 mmHg
Standard Deviation 19.1
|
-25.0 mmHg
Standard Deviation 17.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 13
|
-18.5 mmHg
Standard Deviation 16.9
|
-21.7 mmHg
Standard Deviation 23.5
|
-22.7 mmHg
Standard Deviation 18.3
|
-24.7 mmHg
Standard Deviation 14.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 14
|
-16.7 mmHg
Standard Deviation 17.6
|
-21.6 mmHg
Standard Deviation 20.8
|
-21.7 mmHg
Standard Deviation 19.2
|
-20.2 mmHg
Standard Deviation 16.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 15
|
-15.7 mmHg
Standard Deviation 18.1
|
-19.4 mmHg
Standard Deviation 20.5
|
-19.0 mmHg
Standard Deviation 20.2
|
-18.9 mmHg
Standard Deviation 15.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 16
|
-17.0 mmHg
Standard Deviation 16.9
|
-17.7 mmHg
Standard Deviation 20.0
|
-18.0 mmHg
Standard Deviation 16.0
|
-19.8 mmHg
Standard Deviation 15.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 17
|
-17.3 mmHg
Standard Deviation 17.3
|
-17.9 mmHg
Standard Deviation 20.3
|
-14.7 mmHg
Standard Deviation 15.8
|
-19.1 mmHg
Standard Deviation 15.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 18
|
-17.5 mmHg
Standard Deviation 18.6
|
-17.4 mmHg
Standard Deviation 16.4
|
-15.1 mmHg
Standard Deviation 16.8
|
-19.6 mmHg
Standard Deviation 16.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 19
|
-16.5 mmHg
Standard Deviation 15.6
|
-19.7 mmHg
Standard Deviation 18.4
|
-16.9 mmHg
Standard Deviation 15.3
|
-20.9 mmHg
Standard Deviation 17.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 20
|
-17.8 mmHg
Standard Deviation 16.4
|
-18.0 mmHg
Standard Deviation 17.4
|
-16.5 mmHg
Standard Deviation 15.3
|
-24.4 mmHg
Standard Deviation 14.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 21
|
-17.5 mmHg
Standard Deviation 15.9
|
-17.8 mmHg
Standard Deviation 17.6
|
-15.7 mmHg
Standard Deviation 16.4
|
-22.7 mmHg
Standard Deviation 15.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 22
|
-16.2 mmHg
Standard Deviation 15.9
|
-15.7 mmHg
Standard Deviation 17.0
|
-15.5 mmHg
Standard Deviation 18.7
|
-23.8 mmHg
Standard Deviation 13.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 23
|
-14.4 mmHg
Standard Deviation 14.6
|
-18.9 mmHg
Standard Deviation 16.1
|
-16.5 mmHg
Standard Deviation 19.1
|
-22.4 mmHg
Standard Deviation 14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Hour 24
|
-15.8 mmHg
Standard Deviation 14.9
|
-20.7 mmHg
Standard Deviation 16.3
|
-18.5 mmHg
Standard Deviation 18.1
|
-19.9 mmHg
Standard Deviation 13.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)Population: 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.
Observed results - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=57 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=57 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=56 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=52 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ABPM 24-hour Mean DBP
|
-11 mmHg
Standard Deviation 7.2
|
-13.2 mmHg
Standard Deviation 7.7
|
-12.8 mmHg
Standard Deviation 7.4
|
-14.6 mmHg
Standard Deviation 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)Population: 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.
Observed results - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=57 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=57 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=56 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=52 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ABPM 24-hour Mean SBP
|
-17.3 mmHg
Standard Deviation 10.4
|
-20.5 mmHg
Standard Deviation 13.9
|
-19.5 mmHg
Standard Deviation 11.6
|
-22.4 mmHg
Standard Deviation 9.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: 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)
Calculated as seated minus standing for all patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=133 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=112 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=132 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=121 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Orthostatic Change in Trough Cuff Mean DBP
|
2.2 mmHg
Standard Deviation 5.7
|
1.7 mmHg
Standard Deviation 5.4
|
2 mmHg
Standard Deviation 5.4
|
1.1 mmHg
Standard Deviation 4.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: 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)
Calculated as seated minus standing for all patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=133 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=112 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=132 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=121 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Orthostatic Change in Trough Cuff Mean SBP
|
0 mmHg
Standard Deviation 7.5
|
0.6 mmHg
Standard Deviation 8
|
0.9 mmHg
Standard Deviation 7.5
|
0.8 mmHg
Standard Deviation 7.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End-of-study visit (LOCF)Population: 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)
Observed results for all patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=141 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=123 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=143 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=136 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Pulse Rate
|
0 bpm
Standard Deviation 8.8
|
0 bpm
Standard Deviation 9.5
|
2.4 bpm
Standard Deviation 9.3
|
-1.5 bpm
Standard Deviation 9.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=35 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=33 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=100 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=89 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=34 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=34 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=28 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=30 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=108 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=96 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=36 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=106 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=100 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=37 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=101 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=83 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Cuff Mean SBP
|
-1.9 mmHg
Standard Error 2.1
|
-15.6 mmHg
Standard Error 2.1
|
-15.4 mmHg
Standard Error 1.2
|
-15.4 mmHg
Standard Error 1.3
|
-19 mmHg
Standard Error 2.1
|
-22.1 mmHg
Standard Error 2.1
|
-25.2 mmHg
Standard Error 2.3
|
-23.2 mmHg
Standard Error 2.2
|
-22.2 mmHg
Standard Error 1.2
|
-25.3 mmHg
Standard Error 1.3
|
-17.4 mmHg
Standard Error 2
|
-22.5 mmHg
Standard Error 1.2
|
-26.5 mmHg
Standard Error 1.2
|
-12.4 mmHg
Standard Error 2
|
-14.8 mmHg
Standard Error 1.2
|
-21 mmHg
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=35 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=33 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=99 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=86 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=34 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=34 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=28 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=30 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=107 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=96 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=36 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=105 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=100 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=35 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=101 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=81 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standing Trough Cuff Mean DBP
|
-4.2 mmHg
Standard Error 1.4
|
-11.7 mmHg
Standard Error 1.5
|
-10.9 mmHg
Standard Error 0.9
|
-11.3 mmHg
Standard Error 0.9
|
-15.1 mmHg
Standard Error 1.4
|
-13.3 mmHg
Standard Error 1.4
|
-17.6 mmHg
Standard Error 1.6
|
-17.5 mmHg
Standard Error 1.5
|
-14.2 mmHg
Standard Error 0.8
|
-18 mmHg
Standard Error 0.9
|
-14.5 mmHg
Standard Error 1.4
|
-17.3 mmHg
Standard Error 0.8
|
-19.2 mmHg
Standard Error 0.8
|
-8 mmHg
Standard Error 1.4
|
-11 mmHg
Standard Error 0.8
|
-15.5 mmHg
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
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.
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=35 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=33 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=99 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=86 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=34 Participants
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=34 Participants
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=28 Participants
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=30 Participants
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=107 Participants
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=96 Participants
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=36 Participants
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=105 Participants
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=100 Participants
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
n=35 Participants
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
n=101 Participants
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
n=81 Participants
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Standing Trough Cuff Mean SBP
|
1 mmHg
Standard Error 2.1
|
-13.7 mmHg
Standard Error 2.1
|
-13.6 mmHg
Standard Error 1.2
|
-14 mmHg
Standard Error 1.3
|
-16.2 mmHg
Standard Error 2.1
|
-19.4 mmHg
Standard Error 2.1
|
-23.2 mmHg
Standard Error 2.3
|
-21.8 mmHg
Standard Error 2.2
|
-20.4 mmHg
Standard Error 1.2
|
-22.8 mmHg
Standard Error 1.3
|
-16.3 mmHg
Standard Error 2
|
-21.9 mmHg
Standard Error 1.2
|
-24.3 mmHg
Standard Error 1.2
|
-10.1 mmHg
Standard Error 2.1
|
-13.2 mmHg
Standard Error 1.2
|
-19.3 mmHg
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
DBP control is defined as DBP \< 90 mmHg - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=108 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=96 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=106 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=100 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DBP Control
|
69.4 percentage of participants
|
77.1 percentage of participants
|
68.9 percentage of participants
|
85 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
DBP response is defined as DBP \< 90 mmHg or a reduction of DBP of \>= 10 mmHg - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=108 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=96 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=106 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=100 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DBP Response
|
81.5 percentage of participants
|
89.6 percentage of participants
|
87.7 percentage of participants
|
93 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
SBP Response is defined as SBP \< 140 mmHg or a reduction of SBP of \>= 10 mmHg - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=108 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=96 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=106 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=100 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SBP Response
|
88.9 percentage of participants
|
96.9 percentage of participants
|
84.9 percentage of participants
|
95 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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)
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
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=108 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=96 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=106 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=100 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
BP Normality
No (SBP>=140 and/or DBP>=90)
|
46.3 percentage of participants
|
29.2 percentage of participants
|
41.5 percentage of participants
|
23 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
BP Normality
High Normal (140>SBP>=130 and 90>DBP>=85)
|
25.9 percentage of participants
|
29.2 percentage of participants
|
26.4 percentage of participants
|
27 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
BP Normality
Normal (130>SBP>=120 and 85>DBP>=80)
|
18.5 percentage of participants
|
30.2 percentage of participants
|
21.7 percentage of participants
|
41 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
BP Normality
Optimal (SBP<120 and DBP<80)
|
9.3 percentage of participants
|
11.5 percentage of participants
|
10.4 percentage of participants
|
9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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.
Observed results for mod-sev patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=108 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=96 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=106 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=100 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 1
|
-11 mmHg
Standard Deviation 10.8
|
-16.9 mmHg
Standard Deviation 10.8
|
-13.8 mmHg
Standard Deviation 10.1
|
-13.7 mmHg
Standard Deviation 10.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 2
|
-8.8 mmHg
Standard Deviation 12.3
|
-16.3 mmHg
Standard Deviation 12.5
|
-13.9 mmHg
Standard Deviation 9.3
|
-15.9 mmHg
Standard Deviation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 3
|
-11.2 mmHg
Standard Deviation 14.4
|
-13.8 mmHg
Standard Deviation 11.2
|
-16.4 mmHg
Standard Deviation 11.3
|
-16.1 mmHg
Standard Deviation 11.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 4
|
-10.7 mmHg
Standard Deviation 12.4
|
-16.3 mmHg
Standard Deviation 13.6
|
-15.9 mmHg
Standard Deviation 11.8
|
-16.8 mmHg
Standard Deviation 11.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 5
|
-12.8 mmHg
Standard Deviation 10.5
|
-15.3 mmHg
Standard Deviation 14.3
|
-17.2 mmHg
Standard Deviation 14.3
|
-16.6 mmHg
Standard Deviation 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 6
|
-10.5 mmHg
Standard Deviation 12.2
|
-15.3 mmHg
Standard Deviation 12.6
|
-15.2 mmHg
Standard Deviation 10.1
|
-16.3 mmHg
Standard Deviation 11.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 7
|
-13.8 mmHg
Standard Deviation 11.1
|
-15.3 mmHg
Standard Deviation 11.4
|
-12.9 mmHg
Standard Deviation 10.9
|
-17.5 mmHg
Standard Deviation 14.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 8
|
-13.3 mmHg
Standard Deviation 13.1
|
-19.4 mmHg
Standard Deviation 13.7
|
-13.5 mmHg
Standard Deviation 14.2
|
-17.8 mmHg
Standard Deviation 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 9
|
-14 mmHg
Standard Deviation 11
|
-16.6 mmHg
Standard Deviation 14.2
|
-15.8 mmHg
Standard Deviation 14.3
|
-18.1 mmHg
Standard Deviation 14.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 10
|
-10.7 mmHg
Standard Deviation 11.1
|
-14.6 mmHg
Standard Deviation 14
|
-17 mmHg
Standard Deviation 14.2
|
-20.8 mmHg
Standard Deviation 13.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 11
|
-11.4 mmHg
Standard Deviation 13.9
|
-14.8 mmHg
Standard Deviation 12.6
|
-16.8 mmHg
Standard Deviation 10.5
|
-17.9 mmHg
Standard Deviation 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 12
|
-12.4 mmHg
Standard Deviation 12.2
|
-13.9 mmHg
Standard Deviation 12.4
|
-14.3 mmHg
Standard Deviation 12.2
|
-16.6 mmHg
Standard Deviation 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 13
|
-9.7 mmHg
Standard Deviation 13
|
-14.9 mmHg
Standard Deviation 14.5
|
-14.1 mmHg
Standard Deviation 12.5
|
-15.9 mmHg
Standard Deviation 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 14
|
-8.5 mmHg
Standard Deviation 14.3
|
-14.5 mmHg
Standard Deviation 14.6
|
-15.1 mmHg
Standard Deviation 11.2
|
-12 mmHg
Standard Deviation 14.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 15
|
-10.5 mmHg
Standard Deviation 16.6
|
-10.5 mmHg
Standard Deviation 13.6
|
-13.8 mmHg
Standard Deviation 14.7
|
-10 mmHg
Standard Deviation 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 16
|
-10.9 mmHg
Standard Deviation 15
|
-10.3 mmHg
Standard Deviation 16.3
|
-12.8 mmHg
Standard Deviation 12.2
|
-13.7 mmHg
Standard Deviation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 17
|
-10.1 mmHg
Standard Deviation 14.1
|
-9.8 mmHg
Standard Deviation 14.9
|
-11.5 mmHg
Standard Deviation 12.5
|
-12.3 mmHg
Standard Deviation 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 18
|
-11.8 mmHg
Standard Deviation 15.6
|
-9.9 mmHg
Standard Deviation 13.5
|
-10.6 mmHg
Standard Deviation 10.3
|
-12.8 mmHg
Standard Deviation 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 19
|
-9 mmHg
Standard Deviation 11.7
|
-11.6 mmHg
Standard Deviation 13.9
|
-12.2 mmHg
Standard Deviation 10.6
|
-12.5 mmHg
Standard Deviation 11.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 20
|
-10 mmHg
Standard Deviation 12.3
|
-10.9 mmHg
Standard Deviation 13.1
|
-13.3 mmHg
Standard Deviation 11.2
|
-15.7 mmHg
Standard Deviation 11.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 21
|
-10.5 mmHg
Standard Deviation 12.3
|
-8.6 mmHg
Standard Deviation 14.3
|
-8.4 mmHg
Standard Deviation 12.1
|
-15.1 mmHg
Standard Deviation 9.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 22
|
-10.9 mmHg
Standard Deviation 11.3
|
-10 mmHg
Standard Deviation 14.6
|
-10.2 mmHg
Standard Deviation 13.5
|
-15.2 mmHg
Standard Deviation 10.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 23
|
-10 mmHg
Standard Deviation 11.8
|
-14 mmHg
Standard Deviation 13.8
|
-10 mmHg
Standard Deviation 12.5
|
-14.3 mmHg
Standard Deviation 8.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Hour 24
|
-9.7 mmHg
Standard Deviation 9.8
|
-13.6 mmHg
Standard Deviation 11.2
|
-13.2 mmHg
Standard Deviation 13.8
|
-14.4 mmHg
Standard Deviation 12.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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.
Observed results for mod-sev patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=41 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=41 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=46 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=41 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ABPM 24-hour Mean DBP
|
-11 mmHg
Standard Deviation 7.7
|
-13.6 mmHg
Standard Deviation 8
|
-13.6 mmHg
Standard Deviation 7.1
|
-15.3 mmHg
Standard Deviation 7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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.
Observed results for mod-sev patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=41 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=41 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=46 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=41 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ABPM 24-hour Mean SBP
|
-16.7 mmHg
Standard Deviation 11.3
|
-20.8 mmHg
Standard Deviation 14.1
|
-20.9 mmHg
Standard Deviation 11
|
-22.7 mmHg
Standard Deviation 9.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: 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).
Calculated as seated minus standing for mod-sev patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=102 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=87 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=99 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=88 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Orthostatic Change in Trough Cuff Mean DBP
|
2.5 mmHg
Standard Deviation 5.1
|
2 mmHg
Standard Deviation 5.7
|
1.4 mmHg
Standard Deviation 5.3
|
1.6 mmHg
Standard Deviation 4.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: 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).
Calculated as seated minus standing for mod-sev patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=102 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=87 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=99 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=88 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Orthostatic Change in Trough Cuff Mean SBP
|
0 mmHg
Standard Deviation 7.1
|
1.4 mmHg
Standard Deviation 8.1
|
0.1 mmHg
Standard Deviation 6.9
|
1.1 mmHg
Standard Deviation 6.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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).
Observed results for mod-sev patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=108 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=96 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=106 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=100 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Pulse Rate
|
0.5 bpm
Standard Deviation 8.8
|
0 bpm
Standard Deviation 9
|
2.5 bpm
Standard Deviation 9.2
|
-1.9 bpm
Standard Deviation 8.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Treated set
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).
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=46 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=307 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=319 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=789 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Alanine aminotransferase increased
|
0.0 percentage of participants
|
0.3 percentage of participants
|
0.0 percentage of participants
|
0.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Aspartate aminotransferase increased
|
0.0 percentage of participants
|
0.3 percentage of participants
|
0.0 percentage of participants
|
0.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Blood potassium increased
|
0.0 percentage of participants
|
0.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Electrocardiogram QT shortened
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.3 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Electrocardiogram T wave abnormal
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.3 percentage of participants
|
0.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Electrocardiogram repolarisation abnormality
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Heart rate irregular
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.3 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
QRS axis abnormal
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.3 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Atrioventricular block first degree
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Left atrial dilatation
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Myocardial ischaemia
|
0.0 percentage of participants
|
0.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Palpitation
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.6 percentage of participants
|
0.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Sinus bradycardia
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to nominal week over the trialPopulation: 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).
Observed results for key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=137 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=121 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=139 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=135 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP
Week 2
|
-14.5 mmHg
Standard Deviation 8.76
|
-14.4 mmHg
Standard Deviation 7.62
|
-15.3 mmHg
Standard Deviation 7.87
|
-14.6 mmHg
Standard Deviation 6.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP
Week 4 (N=133, 115, 135, 129)
|
-16.0 mmHg
Standard Deviation 7.24
|
-18.1 mmHg
Standard Deviation 8.52
|
-17.2 mmHg
Standard Deviation 7.56
|
-18.8 mmHg
Standard Deviation 7.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP
Week 6 (N=134, 118, 131, 124)
|
-17.1 mmHg
Standard Deviation 8.59
|
-19.0 mmHg
Standard Deviation 8.30
|
-18.0 mmHg
Standard Deviation 8.02
|
-20.0 mmHg
Standard Deviation 8.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP
Week 8 (N=133, 112, 132, 121)
|
-16.3 mmHg
Standard Deviation 7.42
|
-19.5 mmHg
Standard Deviation 8.03
|
-18.3 mmHg
Standard Deviation 8.28
|
-20.0 mmHg
Standard Deviation 7.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End-of-study (up to 8 weeks) visit (LOCF)Population: 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).
Percentage of responders (SBP\<140 mmHg and DBP\<90 mmHg) for all patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=141 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=123 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=143 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=136 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
BP Control
|
58.9 percentage of participants
|
75.6 percentage of participants
|
65.7 percentage of participants
|
76.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Nominal week over the trialPopulation: 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).
Observed results for mod-sev patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=105 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=94 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=104 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=100 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Seated Trough Cuff DBP
Week 2
|
-14.7 mmHg
Standard Deviation 8.9
|
-14.7 mmHg
Standard Deviation 7.8
|
-16.1 mmHg
Standard Deviation 7.9
|
-14.9 mmHg
Standard Deviation 6.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Seated Trough Cuff DBP
Week 4 (N=102, 90, 102, 96)
|
-16.5 mmHg
Standard Deviation 6.8
|
-18.2 mmHg
Standard Deviation 9.2
|
-17.8 mmHg
Standard Deviation 7.6
|
-19.2 mmHg
Standard Deviation 6.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Seated Trough Cuff DBP
Week 6 (N=102, 92, 98, 96)
|
-17.9 mmHg
Standard Deviation 7.8
|
-19.7 mmHg
Standard Deviation 8.7
|
-18.9 mmHg
Standard Deviation 8.2
|
-19.5 mmHg
Standard Deviation 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Seated Trough Cuff DBP
Week 8 (N=102, 87, 99, 88)
|
-17.1 mmHg
Standard Deviation 7.4
|
-19.4 mmHg
Standard Deviation 8.5
|
-19.3 mmHg
Standard Deviation 8.7
|
-21.1 mmHg
Standard Deviation 7.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 weeks (LOCF)Population: 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).
Responders SBP\<10 mmHg and DBP\<90 mmHg) for mod-sev patients - key combination therapies
Outcome measures
| Measure |
Telmisartan 0 mg (T0)
n=108 Participants
Overall: including Pl, A2.5, A5, and A10 treated groups
|
Telmisartan 20 mg (T20)
n=96 Participants
Overall: including all treatment groups involving T20
|
Telmisartan 40 mg (T40)
n=106 Participants
Overall: including all treatment groups involving T40
|
Telmisartan 80 mg (T80)
n=100 Participants
Overall: including all treatment groups involving T80
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
T20mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
T20mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
T40mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
T40mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
T80mg tab plus encapsulated A2.5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
T80mg tab plus encapsulated A5mg capsule, QD in morning
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
|
Amlodipine 2.5 mg (A2.5)
encapsulated Amlodipine 2.5 mg capsule, QD in morning
|
Amlodipine 5 mg (A5)
encapsulated Amlodipine 5 mg capsule, QD in morning
|
Amlodipine 10 mg (A10)
2 encapsulated Amlodipine 5 mg capsule, QD in morning
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
BP Control
|
53.7 percentage of participants
|
70.8 percentage of participants
|
58.5 percentage of participants
|
77 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
PLACEBO
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Telmisartan 20 mg (T20)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Telmisartan 40 mg (T40)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Telmisartan 80 mg (T80)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Amlodipine 2.5 mg (A2.5)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Amlodipine 5 mg (A5)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Amlodipine 10 mg (A10)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLACEBO
n=46 participants at risk
|
Telmisartan 20 mg (T20)
n=42 participants at risk
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=44 participants at risk
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=46 participants at risk
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=44 participants at risk
|
Telmisartan 40 mg (T40)
n=130 participants at risk
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=47 participants at risk
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=143 participants at risk
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=129 participants at risk
|
Telmisartan 80 mg (T80)
n=135 participants at risk
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=48 participants at risk
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=146 participants at risk
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=142 participants at risk
|
Amlodipine 2.5 mg (A2.5)
n=50 participants at risk
|
Amlodipine 5 mg (A5)
n=140 participants at risk
|
Amlodipine 10 mg (A10)
n=129 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/46
|
0.00%
0/42
|
0.00%
0/44
|
0.00%
0/46
|
0.00%
0/44
|
0.00%
0/130
|
0.00%
0/47
|
0.00%
0/143
|
0.00%
0/129
|
0.00%
0/135
|
2.1%
1/48
|
0.68%
1/146
|
0.00%
0/142
|
0.00%
0/50
|
0.00%
0/140
|
0.00%
0/129
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/46
|
0.00%
0/42
|
0.00%
0/44
|
0.00%
0/46
|
0.00%
0/44
|
0.00%
0/130
|
0.00%
0/47
|
0.00%
0/143
|
0.00%
0/129
|
0.00%
0/135
|
0.00%
0/48
|
0.00%
0/146
|
0.00%
0/142
|
0.00%
0/50
|
0.71%
1/140
|
0.00%
0/129
|
|
Infections and infestations
Sinusitis
|
0.00%
0/46
|
0.00%
0/42
|
0.00%
0/44
|
0.00%
0/46
|
0.00%
0/44
|
0.00%
0/130
|
0.00%
0/47
|
0.00%
0/143
|
0.00%
0/129
|
0.00%
0/135
|
2.1%
1/48
|
0.00%
0/146
|
0.00%
0/142
|
0.00%
0/50
|
0.00%
0/140
|
0.00%
0/129
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/46
|
0.00%
0/42
|
0.00%
0/44
|
0.00%
0/46
|
0.00%
0/44
|
0.00%
0/130
|
0.00%
0/47
|
0.00%
0/143
|
0.00%
0/129
|
0.74%
1/135
|
0.00%
0/48
|
0.00%
0/146
|
0.00%
0/142
|
0.00%
0/50
|
0.00%
0/140
|
0.00%
0/129
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/46
|
0.00%
0/42
|
0.00%
0/44
|
0.00%
0/46
|
0.00%
0/44
|
0.00%
0/130
|
0.00%
0/47
|
0.00%
0/143
|
0.00%
0/129
|
0.00%
0/135
|
0.00%
0/48
|
0.00%
0/146
|
0.00%
0/142
|
2.0%
1/50
|
0.00%
0/140
|
0.00%
0/129
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/46
|
0.00%
0/42
|
0.00%
0/44
|
0.00%
0/46
|
0.00%
0/44
|
0.00%
0/130
|
0.00%
0/47
|
0.00%
0/143
|
0.00%
0/129
|
0.00%
0/135
|
0.00%
0/48
|
0.68%
1/146
|
0.00%
0/142
|
0.00%
0/50
|
0.00%
0/140
|
0.00%
0/129
|
Other adverse events
| Measure |
PLACEBO
n=46 participants at risk
|
Telmisartan 20 mg (T20)
n=42 participants at risk
|
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)
n=44 participants at risk
|
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)
n=46 participants at risk
|
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)
n=44 participants at risk
|
Telmisartan 40 mg (T40)
n=130 participants at risk
|
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)
n=47 participants at risk
|
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)
n=143 participants at risk
|
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)
n=129 participants at risk
|
Telmisartan 80 mg (T80)
n=135 participants at risk
|
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)
n=48 participants at risk
|
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)
n=146 participants at risk
|
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)
n=142 participants at risk
|
Amlodipine 2.5 mg (A2.5)
n=50 participants at risk
|
Amlodipine 5 mg (A5)
n=140 participants at risk
|
Amlodipine 10 mg (A10)
n=129 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chest pain
|
2.2%
1/46
|
7.1%
3/42
|
0.00%
0/44
|
0.00%
0/46
|
0.00%
0/44
|
1.5%
2/130
|
0.00%
0/47
|
0.70%
1/143
|
0.78%
1/129
|
0.00%
0/135
|
0.00%
0/48
|
0.68%
1/146
|
0.00%
0/142
|
0.00%
0/50
|
0.00%
0/140
|
0.78%
1/129
|
|
General disorders
Oedema peripheral
|
0.00%
0/46
|
0.00%
0/42
|
2.3%
1/44
|
4.3%
2/46
|
11.4%
5/44
|
0.77%
1/130
|
0.00%
0/47
|
1.4%
2/143
|
5.4%
7/129
|
0.74%
1/135
|
2.1%
1/48
|
2.1%
3/146
|
11.3%
16/142
|
2.0%
1/50
|
0.71%
1/140
|
17.8%
23/129
|
|
Nervous system disorders
Headache
|
10.9%
5/46
|
7.1%
3/42
|
6.8%
3/44
|
8.7%
4/46
|
4.5%
2/44
|
8.5%
11/130
|
6.4%
3/47
|
4.9%
7/143
|
3.9%
5/129
|
3.0%
4/135
|
0.00%
0/48
|
4.1%
6/146
|
4.9%
7/142
|
4.0%
2/50
|
6.4%
9/140
|
5.4%
7/129
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER