Trial Outcomes & Findings for Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension (NCT NCT00860262)
NCT ID: NCT00860262
Last Updated: 2014-05-20
Results Overview
Overall mean reduction from a common mean baseline in SBP
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
858 participants
Primary outcome timeframe
baseline and week 8
Results posted on
2014-05-20
Participant Flow
Participant milestones
| Measure |
T80+A10
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Overall Study
STARTED
|
421
|
217
|
220
|
|
Overall Study
COMPLETED
|
401
|
195
|
202
|
|
Overall Study
NOT COMPLETED
|
20
|
22
|
18
|
Reasons for withdrawal
| Measure |
T80+A10
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
6
|
7
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
6
|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
3
|
|
Overall Study
Other
|
5
|
3
|
1
|
Baseline Characteristics
Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
Baseline characteristics by cohort
| Measure |
T80+A10
n=421 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=217 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=220 Participants
Amlodipine 10 mg once daily (A10)
|
Total
n=858 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Age, Customized
< 65 years
|
309 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
623 Participants
n=4 Participants
|
|
Age, Customized
>= 65 years
|
112 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
413 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
219 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
445 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
362 participants
n=5 Participants
|
186 participants
n=7 Participants
|
190 participants
n=5 Participants
|
738 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
34 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
64 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
48 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
30.6 kilograms/square meter
STANDARD_DEVIATION 5.9 • n=5 Participants
|
30.2 kilograms/square meter
STANDARD_DEVIATION 5.2 • n=7 Participants
|
30.7 kilograms/square meter
STANDARD_DEVIATION 6.3 • n=5 Participants
|
30.6 kilograms/square meter
STANDARD_DEVIATION 5.8 • n=4 Participants
|
|
Body Mass Index Class
BMI < 25
|
63 participants
n=5 Participants
|
31 participants
n=7 Participants
|
35 participants
n=5 Participants
|
129 participants
n=4 Participants
|
|
Body Mass Index Class
25 <= BMI < 30
|
160 participants
n=5 Participants
|
79 participants
n=7 Participants
|
82 participants
n=5 Participants
|
321 participants
n=4 Participants
|
|
Body Mass Index Class
BMI >= 30
|
198 participants
n=5 Participants
|
107 participants
n=7 Participants
|
103 participants
n=5 Participants
|
408 participants
n=4 Participants
|
|
Race Class
Non-Black
|
387 participants
n=5 Participants
|
202 participants
n=7 Participants
|
205 participants
n=5 Participants
|
794 participants
n=4 Participants
|
|
Race Class
Black
|
34 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
64 participants
n=4 Participants
|
|
Type II Diabetes
No
|
349 participants
n=5 Participants
|
183 participants
n=7 Participants
|
197 participants
n=5 Participants
|
729 participants
n=4 Participants
|
|
Type II Diabetes
Yes
|
72 participants
n=5 Participants
|
34 participants
n=7 Participants
|
23 participants
n=5 Participants
|
129 participants
n=4 Participants
|
|
Duration of Hypertension
|
10.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
9.4 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
10.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
10.1 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Duration of Hypertension Class
< 1 year
|
38 participants
n=5 Participants
|
25 participants
n=7 Participants
|
20 participants
n=5 Participants
|
83 participants
n=4 Participants
|
|
Duration of Hypertension Class
1 - 5 years
|
124 participants
n=5 Participants
|
64 participants
n=7 Participants
|
72 participants
n=5 Participants
|
260 participants
n=4 Participants
|
|
Duration of Hypertension Class
6 - 10 years
|
103 participants
n=5 Participants
|
61 participants
n=7 Participants
|
54 participants
n=5 Participants
|
218 participants
n=4 Participants
|
|
Duration of Hypertension Class
> 10 years
|
156 participants
n=5 Participants
|
67 participants
n=7 Participants
|
74 participants
n=5 Participants
|
297 participants
n=4 Participants
|
|
Number of previous antihypertensive treatments
0
|
49 participants
n=5 Participants
|
37 participants
n=7 Participants
|
26 participants
n=5 Participants
|
112 participants
n=4 Participants
|
|
Number of previous antihypertensive treatments
1
|
133 participants
n=5 Participants
|
67 participants
n=7 Participants
|
78 participants
n=5 Participants
|
278 participants
n=4 Participants
|
|
Number of previous antihypertensive treatments
2
|
136 participants
n=5 Participants
|
59 participants
n=7 Participants
|
71 participants
n=5 Participants
|
266 participants
n=4 Participants
|
|
Number of previous antihypertensive treatments
>= 3
|
103 participants
n=5 Participants
|
54 participants
n=7 Participants
|
45 participants
n=5 Participants
|
202 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and week 8Population: Full analysis set (FAS) included all randomised patients who had at least one seated trough cuff SBP following administration of study drug.
Overall mean reduction from a common mean baseline in SBP
Outcome measures
| Measure |
T80+A10
n=379 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=189 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=195 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8
|
-47.5 mmHg (millimeters of mercury)
Standard Error 0.69
|
-36.9 mmHg (millimeters of mercury)
Standard Error 0.96
|
-43.2 mmHg (millimeters of mercury)
Standard Error 0.95
|
SECONDARY outcome
Timeframe: baseline and week 6Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
Overall mean reduction from a common mean baseline in SBP
Outcome measures
| Measure |
T80+A10
n=390 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=197 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=201 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6
|
-46.9 mmHg (millimeters of mercury)
Standard Error 0.73
|
-36.3 mmHg (millimeters of mercury)
Standard Error 1.01
|
-42.1 mmHg (millimeters of mercury)
Standard Error 1.01
|
SECONDARY outcome
Timeframe: baseline and week 4Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
Overall mean reduction from a common mean baseline in SBP
Outcome measures
| Measure |
T80+A10
n=392 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=202 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=203 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4
|
-44.5 mmHg (millimeters of mercury)
Standard Error 0.73
|
-34.4 mmHg (millimeters of mercury)
Standard Error 1.01
|
-39.8 mmHg (millimeters of mercury)
Standard Error 1.01
|
SECONDARY outcome
Timeframe: baseline and week 2Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
Overall mean reduction from a common mean baseline in SBP
Outcome measures
| Measure |
T80+A10
n=395 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=208 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=204 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2
|
-37.9 mmHg (millimeters of mercury)
Standard Error 0.71
|
-30.1 mmHg (millimeters of mercury)
Standard Error 0.97
|
-33.3 mmHg (millimeters of mercury)
Standard Error 0.98
|
SECONDARY outcome
Timeframe: baseline and week 1Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
Overall mean reduction from a common mean baseline in SBP
Outcome measures
| Measure |
T80+A10
n=387 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=207 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=207 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1
|
-31.9 mmHg (millimeters of mercury)
Standard Error 0.72
|
-25.4 mmHg (millimeters of mercury)
Standard Error 0.99
|
-28.6 mmHg (millimeters of mercury)
Standard Error 0.99
|
SECONDARY outcome
Timeframe: baseline and week 8Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
Overall mean reduction from a common mean baseline in DBP
Outcome measures
| Measure |
T80+A10
n=379 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=189 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=195 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8
|
-18.7 mmHg (millimeters of mercury)
Standard Error 0.41
|
-13.8 mmHg (millimeters of mercury)
Standard Error 0.58
|
-16.3 mmHg (millimeters of mercury)
Standard Error 0.58
|
SECONDARY outcome
Timeframe: baseline and week 6Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
Overall mean reduction from a common mean baseline in DBP
Outcome measures
| Measure |
T80+A10
n=390 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=197 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=201 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6
|
-18.3 mmHg (millimeters of mercury)
Standard Error 0.41
|
-13.5 mmHg (millimeters of mercury)
Standard Error 0.57
|
-15.7 mmHg (millimeters of mercury)
Standard Error 0.57
|
SECONDARY outcome
Timeframe: baseline and week 4Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
Overall mean reduction from a common mean baseline in DBP
Outcome measures
| Measure |
T80+A10
n=392 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=202 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=203 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4
|
-17.0 mmHg (millimeters of mercury)
Standard Error 0.43
|
-12.1 mmHg (millimeters of mercury)
Standard Error 0.60
|
-14.2 mmHg (millimeters of mercury)
Standard Error 0.60
|
SECONDARY outcome
Timeframe: baseline and week 2Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
Overall mean reduction from a common mean baseline in DBP
Outcome measures
| Measure |
T80+A10
n=395 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=208 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=204 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2
|
-13.2 mmHg (millimeters of mercury)
Standard Error 0.40
|
-10.4 mmHg (millimeters of mercury)
Standard Error 0.56
|
-11.4 mmHg (millimeters of mercury)
Standard Error 0.56
|
SECONDARY outcome
Timeframe: baseline and week 1Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
Overall mean reduction from a common mean baseline in DBP
Outcome measures
| Measure |
T80+A10
n=387 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=207 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=207 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1
|
-10.9 mmHg (millimeters of mercury)
Standard Error 0.37
|
-8.2 mmHg (millimeters of mercury)
Standard Error 0.50
|
-9.6 mmHg (millimeters of mercury)
Standard Error 0.50
|
SECONDARY outcome
Timeframe: week 1Population: Full analysis set, imputation method used was last observation carried forward (LOCF).
Diastolic Blood Pressure Control is defined as achieving DBP \< 90mmHg
Outcome measures
| Measure |
T80+A10
n=387 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=207 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=207 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Control at Week 1
Controlled
|
147 participants
|
61 participants
|
64 participants
|
|
Patients Achieving Diastolic Blood Pressure Control at Week 1
Not Controlled
|
240 participants
|
146 participants
|
143 participants
|
SECONDARY outcome
Timeframe: week 2Population: FAS (LOCF)
DBP \< 90 mmHg
Outcome measures
| Measure |
T80+A10
n=405 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=212 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Control at Week 2
Controlled
|
205 participants
|
87 participants
|
91 participants
|
|
Patients Achieving Diastolic Blood Pressure Control at Week 2
Not Controlled
|
200 participants
|
125 participants
|
121 participants
|
SECONDARY outcome
Timeframe: week 1Population: FAS (LOCF)
Blood Pressure Control is defined as achieving SBP\< 140 mmHg and DBP \< 90mmHg
Outcome measures
| Measure |
T80+A10
n=387 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=207 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=207 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Blood Pressure Control at Week 1
Controlled
|
54 participants
|
16 participants
|
15 participants
|
|
Patients Achieving Blood Pressure Control at Week 1
Not Controlled
|
333 participants
|
191 participants
|
192 participants
|
SECONDARY outcome
Timeframe: week 2Population: FAS (LOCF)
SBP \< 140 mmHg and DBP \< 90 mmHg
Outcome measures
| Measure |
T80+A10
n=405 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=212 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Blood Pressure Control at Week 2
Controlled
|
88 participants
|
30 participants
|
28 participants
|
|
Patients Achieving Blood Pressure Control at Week 2
Not Controlled
|
317 participants
|
182 participants
|
184 participants
|
SECONDARY outcome
Timeframe: baseline, week 1Population: FAS (LOCF)
Diastolic Blood Pressure Response is defined as achieving DBP \< 90 mmHg or a reduction of \>= 10 mmHg
Outcome measures
| Measure |
T80+A10
n=387 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=207 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=207 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Response at Week 1
Controlled
|
232 participants
|
95 participants
|
100 participants
|
|
Patients Achieving Diastolic Blood Pressure Response at Week 1
Not Controlled
|
155 participants
|
112 participants
|
107 participants
|
SECONDARY outcome
Timeframe: baseline, week 2Population: FAS (LOCF)
DBP \< 90 mmHg or reduction of \>= 10 mmHg
Outcome measures
| Measure |
T80+A10
n=405 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=212 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Response at Week 2
Controlled
|
289 participants
|
123 participants
|
128 participants
|
|
Patients Achieving Diastolic Blood Pressure Response at Week 2
Not Controlled
|
116 participants
|
89 participants
|
84 participants
|
SECONDARY outcome
Timeframe: baseline, week 1Population: FAS (LOCF)
Systolic Blood Pressure Response Control is defined as achieving SBP \< 140 mmHg or a reduction of \>= 15 mmHg
Outcome measures
| Measure |
T80+A10
n=387 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=207 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=207 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Systolic Blood Pressure Response at Week 1
Controlled
|
338 participants
|
164 participants
|
173 participants
|
|
Patients Achieving Systolic Blood Pressure Response at Week 1
Not Controlled
|
49 participants
|
43 participants
|
34 participants
|
SECONDARY outcome
Timeframe: baseline, week 2Population: FAS (LOCF)
SBP \< 140 mmHg or reduction of \>= 15 mmHg
Outcome measures
| Measure |
T80+A10
n=405 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=212 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Systolic Blood Pressure Response at Week 2
Controlled
|
387 participants
|
169 participants
|
189 participants
|
|
Patients Achieving Systolic Blood Pressure Response at Week 2
Not Controlled
|
18 participants
|
43 participants
|
23 participants
|
SECONDARY outcome
Timeframe: week 1Population: FAS (LOCF)
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Outcome measures
| Measure |
T80+A10
n=387 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=207 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=207 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
Optimal
|
3 participants
|
0 participants
|
0 participants
|
|
Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
Normal
|
9 participants
|
3 participants
|
3 participants
|
|
Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
High Normal
|
42 participants
|
13 participants
|
12 participants
|
|
Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
High
|
333 participants
|
191 participants
|
192 participants
|
SECONDARY outcome
Timeframe: week 2Population: FAS (LOCF)
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Outcome measures
| Measure |
T80+A10
n=405 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=212 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
Optimal
|
6 participants
|
0 participants
|
0 participants
|
|
Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
Normal
|
21 participants
|
7 participants
|
5 participants
|
|
Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
High Normal
|
61 participants
|
23 participants
|
23 participants
|
|
Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
High
|
317 participants
|
182 participants
|
184 participants
|
SECONDARY outcome
Timeframe: week 4Population: FAS (LOCF)
DBP \< 90 mmHg
Outcome measures
| Measure |
T80+A10
n=392 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=203 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Control at Week 4
Controlled
|
268 participants
|
106 participants
|
109 participants
|
|
Patients Achieving Diastolic Blood Pressure Control at Week 4
Not Controlled
|
124 participants
|
106 participants
|
94 participants
|
SECONDARY outcome
Timeframe: week 6Population: FAS (LOCF)
DBP \< 90 mmHg
Outcome measures
| Measure |
T80+A10
n=394 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Control at Week 6
Controlled
|
290 participants
|
110 participants
|
128 participants
|
|
Patients Achieving Diastolic Blood Pressure Control at Week 6
Not Controlled
|
104 participants
|
102 participants
|
77 participants
|
SECONDARY outcome
Timeframe: week 8Population: FAS (LOCF)
DBP \< 90 mmHg
Outcome measures
| Measure |
T80+A10
n=394 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Control at Week 8
Controlled
|
291 participants
|
112 participants
|
131 participants
|
|
Patients Achieving Diastolic Blood Pressure Control at Week 8
Not Controlled
|
103 participants
|
100 participants
|
74 participants
|
SECONDARY outcome
Timeframe: week 4Population: FAS (LOCF)
SBP \< 140 mmHg and DBP \< 90 mmHg
Outcome measures
| Measure |
T80+A10
n=392 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=203 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Blood Pressure Control at Week 4
Controlled
|
161 participants
|
49 participants
|
53 participants
|
|
Patients Achieving Blood Pressure Control at Week 4
Not Controlled
|
231 participants
|
163 participants
|
150 participants
|
SECONDARY outcome
Timeframe: week 6Population: FAS (LOCF)
SBP \< 140 mmHg and DBP \< 90 mmHg
Outcome measures
| Measure |
T80+A10
n=394 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Blood Pressure Control at Week 6
Controlled
|
196 participants
|
54 participants
|
77 participants
|
|
Patients Achieving Blood Pressure Control at Week 6
Not Controlled
|
198 participants
|
158 participants
|
128 participants
|
SECONDARY outcome
Timeframe: week 8Population: FAS (LOCF)
SBP \< 140 mmHg and DBP \< 90 mmHg
Outcome measures
| Measure |
T80+A10
n=395 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Blood Pressure Control at Week 8
Controlled
|
199 participants
|
51 participants
|
73 participants
|
|
Patients Achieving Blood Pressure Control at Week 8
Not Controlled
|
196 participants
|
161 participants
|
132 participants
|
SECONDARY outcome
Timeframe: baseline, week 4Population: FAS (LOCF)
DBP \< 90 mmHg or reduction of \>= 10 mmHg
Outcome measures
| Measure |
T80+A10
n=392 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=212 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Response at Week 4
Controlled
|
339 participants
|
132 participants
|
151 participants
|
|
Patients Achieving Diastolic Blood Pressure Response at Week 4
Not Controlled
|
53 participants
|
80 participants
|
61 participants
|
SECONDARY outcome
Timeframe: baseline, week 6Population: FAS (LOCF)
DBP \< 90 mmHg or reduction of \>= 10 mmHg
Outcome measures
| Measure |
T80+A10
n=394 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Response at Week 6
Controlled
|
356 participants
|
144 participants
|
168 participants
|
|
Patients Achieving Diastolic Blood Pressure Response at Week 6
Not Controlled
|
38 participants
|
68 participants
|
37 participants
|
SECONDARY outcome
Timeframe: baseline, week 8Population: FAS (LOCF)
DBP \< 90 mmHg or reduction of \>= 10 mmHg
Outcome measures
| Measure |
T80+A10
n=395 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Diastolic Blood Pressure Response at Week 8
Controlled
|
361 participants
|
147 participants
|
172 participants
|
|
Patients Achieving Diastolic Blood Pressure Response at Week 8
Not Controlled
|
34 participants
|
65 participants
|
33 participants
|
SECONDARY outcome
Timeframe: baseline, week 4Population: FAS (LOCF)
SBP \< 140 mmHg or reduction of \>= 15 mmHg
Outcome measures
| Measure |
T80+A10
n=392 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=203 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Systolic Blood Pressure Response at Week 4
Controlled
|
388 participants
|
180 participants
|
194 participants
|
|
Patients Achieving Systolic Blood Pressure Response at Week 4
Not Controlled
|
4 participants
|
32 participants
|
9 participants
|
SECONDARY outcome
Timeframe: baseline, week 6Population: FAS (LOCF)
SBP \< 140 mmHg or reduction of \>= 15 mmHg
Outcome measures
| Measure |
T80+A10
n=394 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Systolic Blood Pressure Response at Week 6
Controlled
|
388 participants
|
184 participants
|
201 participants
|
|
Patients Achieving Systolic Blood Pressure Response at Week 6
Not Controlled
|
6 participants
|
28 participants
|
4 participants
|
SECONDARY outcome
Timeframe: baseline, week 8Population: FAS (LOCF)
SBP \< 140 mmHg or reduction of \>= 15 mmHg
Outcome measures
| Measure |
T80+A10
n=395 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Systolic Blood Pressure Response at Week 8
Controlled
|
391 participants
|
188 participants
|
202 participants
|
|
Patients Achieving Systolic Blood Pressure Response at Week 8
Not Controlled
|
4 participants
|
24 participants
|
3 participants
|
SECONDARY outcome
Timeframe: week 4Population: FAS (LOCF)
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Outcome measures
| Measure |
T80+A10
n=392 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=203 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Normal Blood Pressure Response at Week 4
Optimal
|
15 participants
|
4 participants
|
2 participants
|
|
Patients Achieving Normal Blood Pressure Response at Week 4
Normal
|
47 participants
|
15 participants
|
14 participants
|
|
Patients Achieving Normal Blood Pressure Response at Week 4
High Normal
|
99 participants
|
30 participants
|
37 participants
|
|
Patients Achieving Normal Blood Pressure Response at Week 4
High
|
231 participants
|
163 participants
|
150 participants
|
SECONDARY outcome
Timeframe: week 6Population: FAS (LOCF)
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Outcome measures
| Measure |
T80+A10
n=394 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Normal Blood Pressure Response at Week 6
Optimal
|
17 participants
|
5 participants
|
3 participants
|
|
Patients Achieving Normal Blood Pressure Response at Week 6
Normal
|
73 participants
|
19 participants
|
18 participants
|
|
Patients Achieving Normal Blood Pressure Response at Week 6
High Normal
|
106 participants
|
30 participants
|
56 participants
|
|
Patients Achieving Normal Blood Pressure Response at Week 6
High
|
198 participants
|
158 participants
|
128 participants
|
SECONDARY outcome
Timeframe: week 8Population: FAS (LOCF)
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Outcome measures
| Measure |
T80+A10
n=395 Participants
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=212 Participants
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=205 Participants
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Patients Achieving Normal Blood Pressure Response at Week 8
Optimal
|
18 participants
|
3 participants
|
2 participants
|
|
Patients Achieving Normal Blood Pressure Response at Week 8
Normal
|
76 participants
|
21 participants
|
25 participants
|
|
Patients Achieving Normal Blood Pressure Response at Week 8
High Normal
|
105 participants
|
27 participants
|
46 participants
|
|
Patients Achieving Normal Blood Pressure Response at Week 8
High
|
196 participants
|
161 participants
|
132 participants
|
Adverse Events
T80+A10
Serious events: 3 serious events
Other events: 67 other events
Deaths: 0 deaths
Telmisartan 80 mg
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Amlodipine 10 mg
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T80+A10
n=421 participants at risk
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=217 participants at risk
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=220 participants at risk
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/421 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/217 • First study medication intake, last study medication intake + 6 days
|
0.45%
1/220 • First study medication intake, last study medication intake + 6 days
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/421 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/217 • First study medication intake, last study medication intake + 6 days
|
0.45%
1/220 • First study medication intake, last study medication intake + 6 days
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.24%
1/421 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/217 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/220 • First study medication intake, last study medication intake + 6 days
|
|
Infections and infestations
Peridiverticular abscess
|
0.24%
1/421 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/217 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/220 • First study medication intake, last study medication intake + 6 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/421 • First study medication intake, last study medication intake + 6 days
|
0.46%
1/217 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/220 • First study medication intake, last study medication intake + 6 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.24%
1/421 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/217 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/220 • First study medication intake, last study medication intake + 6 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/421 • First study medication intake, last study medication intake + 6 days
|
0.46%
1/217 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/220 • First study medication intake, last study medication intake + 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.24%
1/421 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/217 • First study medication intake, last study medication intake + 6 days
|
0.00%
0/220 • First study medication intake, last study medication intake + 6 days
|
Other adverse events
| Measure |
T80+A10
n=421 participants at risk
Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
|
Telmisartan 80 mg
n=217 participants at risk
Telmisartan 80 mg once daily (T80)
|
Amlodipine 10 mg
n=220 participants at risk
Amlodipine 10 mg once daily (A10)
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
13.1%
55/421 • First study medication intake, last study medication intake + 6 days
|
3.7%
8/217 • First study medication intake, last study medication intake + 6 days
|
15.0%
33/220 • First study medication intake, last study medication intake + 6 days
|
|
Nervous system disorders
Headache
|
3.8%
16/421 • First study medication intake, last study medication intake + 6 days
|
8.3%
18/217 • First study medication intake, last study medication intake + 6 days
|
5.5%
12/220 • First study medication intake, last study medication intake + 6 days
|
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