Trial Outcomes & Findings for Telmisartan+Amlodipine Fixed Dose Combination in Hypertension (NCT NCT01204398)
NCT ID: NCT01204398
Last Updated: 2014-06-27
Results Overview
ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
27 participants
Primary outcome timeframe
8 weeks
Results posted on
2014-06-27
Participant Flow
This was an open-label study with one treatment arm. Whilst 40 patients were enrolled, 39 entered the placebo run-in and 27 were treated. Therefore the treated set (TS) comprises 27 patients and the full analysis set (FAS) comprises 25 patients.
Participant milestones
| Measure |
T80/A5
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
T80/A5
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Telmisartan+Amlodipine Fixed Dose Combination in Hypertension
Baseline characteristics by cohort
| Measure |
T80/A5
n=25 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Age, Continuous
|
52.0 Years
STANDARD_DEVIATION 8.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
|
Mean 24-hour mean Diastolic blood pressure (DBP)
|
95.79 mmHg
STANDARD_DEVIATION 7.74 • n=93 Participants
|
|
Mean 24-hour mean Systolic blood pressure (SBP)
|
150.24 mmHg
STANDARD_DEVIATION 17.30 • n=93 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Full analysis set (FAS) defined as all patients with at least one dose of T80/A5, and for whom baseline and post-baseline ABPM are available.
ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.
Outcome measures
| Measure |
T80/A5
n=25 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean
DBP change from baseline
|
-12.76 mmHg
Standard Deviation 7.42
|
|
DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean
SBP change from baseline
|
-23.82 mmHg
Standard Deviation 14.54
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: FAS
Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5
Outcome measures
| Measure |
T80/A5
n=25 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 1 hour
|
-12.5 mmHg
Standard Deviation 10.7
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 2 hours
|
-14.7 mmHg
Standard Deviation 14.2
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 3 hours
|
-13.7 mmHg
Standard Deviation 13.9
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 4 hours
|
-11.7 mmHg
Standard Deviation 10.9
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 5 hours
|
-9.9 mmHg
Standard Deviation 15.6
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 6 hours
|
-11.7 mmHg
Standard Deviation 13.4
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 7 hours
|
-15.9 mmHg
Standard Deviation 12.3
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 8 hours
|
-14.8 mmHg
Standard Deviation 9.2
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 9 hours
|
-13.7 mmHg
Standard Deviation 11.1
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 10 hours
|
-12.9 mmHg
Standard Deviation 13.3
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 11 hours
|
-13.6 mmHg
Standard Deviation 13.0
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 13 hours
|
-13.2 mmHg
Standard Deviation 12.4
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 14 hours
|
-11.9 mmHg
Standard Deviation 14.8
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 15 hours
|
-11.5 mmHg
Standard Deviation 12.8
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 16 hours
|
-11.8 mmHg
Standard Deviation 18.3
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 17 hours
|
-12.6 mmHg
Standard Deviation 14.0
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 18 hours
|
-13.1 mmHg
Standard Deviation 12.2
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 19 hours
|
-11.8 mmHg
Standard Deviation 10.6
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 20 hours
|
-10.7 mmHg
Standard Deviation 13.2
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 21 hours
|
-9.0 mmHg
Standard Deviation 13.4
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 22 hours
|
-13.8 mmHg
Standard Deviation 15.8
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 23 hours
|
-13.9 mmHg
Standard Deviation 9.8
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 24 hour
|
-14.8 mmHg
Standard Deviation 12.1
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 1 hour
|
-25.0 mmHg
Standard Deviation 21.3
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 2 hours
|
-26.2 mmHg
Standard Deviation 22.7
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 10 hours
|
-25.8 mmHg
Standard Deviation 20.2
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 11 hours
|
-22.8 mmHg
Standard Deviation 20.4
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 12 hours
|
-23.4 mmHg
Standard Deviation 19.2
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 13 hours
|
-22.4 mmHg
Standard Deviation 19.5
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 14 hours
|
-22.1 mmHg
Standard Deviation 20.8
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 15 hours
|
-22.9 mmHg
Standard Deviation 19.4
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 16 hours
|
-24.4 mmHg
Standard Deviation 22.5
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 17 hours
|
-23.3 mmHg
Standard Deviation 19.9
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 18 hours
|
-21.7 mmHg
Standard Deviation 22.2
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 19 hours
|
-21.2 mmHg
Standard Deviation 16.8
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 20 hours
|
-20.5 mmHg
Standard Deviation 21.2
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
DBP Change from baseline after 12 hours
|
-13.1 mmHg
Standard Deviation 12.5
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 3 hours
|
-30.1 mmHg
Standard Deviation 26.3
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 4 hours
|
-21.9 mmHg
Standard Deviation 20.3
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 5 hours
|
-23.9 mmHg
Standard Deviation 19.7
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 6 hours
|
-23.9 mmHg
Standard Deviation 22.6
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 7 hours
|
-29.2 mmHg
Standard Deviation 18.8
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 8 hours
|
-27.6 mmHg
Standard Deviation 18.0
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 9 hours
|
-27.7 mmHg
Standard Deviation 21.1
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 21 hours
|
-17.0 mmHg
Standard Deviation 24.6
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 22 hours
|
-19.2 mmHg
Standard Deviation 25.8
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 23 hours
|
-24.6 mmHg
Standard Deviation 15.6
|
|
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
SBP Change from baseline after 24 hour
|
-25.1 mmHg
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: FAS
Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.
Outcome measures
| Measure |
T80/A5
n=25 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment
SBP T/P ratio (N=25)
|
0.98 Ratio
Full Range -7.6, 14.0 • Interval -7.6 to 14.0
|
|
Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment
DBP T/P ratio (N=23)
|
1.13 Ratio
Full Range -14.9, 15.8 • Interval -14.9 to 15.8
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: FAS
Manually measured in-clinic DBP and SBP
Outcome measures
| Measure |
T80/A5
n=25 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Change From Baseline to End of Study in DBP and SBP
DBP: Change from baseline to 2 weeks
|
-9.67 mmHg
Standard Deviation 7.14
|
|
Change From Baseline to End of Study in DBP and SBP
DBP: Change from baseline to 4 weeks
|
-13.49 mmHg
Standard Deviation 7.22
|
|
Change From Baseline to End of Study in DBP and SBP
DBP: Change from baseline to 8 weeks
|
-13.73 mmHg
Standard Deviation 6.58
|
|
Change From Baseline to End of Study in DBP and SBP
SBP: Change from baseline to 2 weeks
|
-11.04 mmHg
Standard Deviation 8.99
|
|
Change From Baseline to End of Study in DBP and SBP
SBP: Change from baseline to 4 weeks
|
-17.95 mmHg
Standard Deviation 10.53
|
|
Change From Baseline to End of Study in DBP and SBP
SBP: Change from baseline to 8 weeks
|
-19.80 mmHg
Standard Deviation 9.96
|
SECONDARY outcome
Timeframe: 0 and 8 weeksPopulation: FAS
DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment
Outcome measures
| Measure |
T80/A5
n=25 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 2 hours at baseline
|
101.7 mmHg
Standard Deviation 13.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 3 hours at baseline
|
100.0 mmHg
Standard Deviation 11.1
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 4 hours at baseline
|
97.9 mmHg
Standard Deviation 9.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 5 hours at baseline
|
95.3 mmHg
Standard Deviation 11.3
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 6 hours at baseline
|
96.5 mmHg
Standard Deviation 11.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 7 hours at baseline
|
97.0 mmHg
Standard Deviation 12.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 8 hours at baseline
|
100.6 mmHg
Standard Deviation 9.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 9 hours at baseline
|
102.7 mmHg
Standard Deviation 10.3
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 10 hours at baseline
|
100.4 mmHg
Standard Deviation 11.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 11 hours at baseline
|
97.9 mmHg
Standard Deviation 11.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 12 hours at baseline
|
95.9 mmHg
Standard Deviation 11.0
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 13 hours at baseline
|
93.6 mmHg
Standard Deviation 11.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 14 hours at baseline
|
92.0 mmHg
Standard Deviation 11.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 15 hours at baseline
|
89.4 mmHg
Standard Deviation 11.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 16 hours at baseline
|
89.1 mmHg
Standard Deviation 16.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 17 hours at baseline
|
88.0 mmHg
Standard Deviation 10.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 18 hours at baseline
|
88.8 mmHg
Standard Deviation 11.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 19 hours at baseline
|
88.4 mmHg
Standard Deviation 10.3
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 21 hours at baseline
|
91.4 mmHg
Standard Deviation 10.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 22 hours at baseline
|
97.6 mmHg
Standard Deviation 14.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 23 hours at baseline
|
101.0 mmHg
Standard Deviation 10.0
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 24 hours at baseline
|
101.8 mmHg
Standard Deviation 9.3
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 1 hour at the end of the study
|
89.1 mmHg
Standard Deviation 8.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 2 hours at the end of the study
|
87.1 mmHg
Standard Deviation 11.0
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 3 hours at the end of the study
|
86.3 mmHg
Standard Deviation 11.1
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 4 hours at the end of the study
|
86.2 mmHg
Standard Deviation 10.1
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 5 hours at the end of the study
|
85.3 mmHg
Standard Deviation 10.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 6 hours at the end of the study
|
84.8 mmHg
Standard Deviation 11.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 7 hours at the end of the study
|
81.1 mmHg
Standard Deviation 12.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 8 hours at the end of the study
|
85.8 mmHg
Standard Deviation 7.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 9 hours at the end of the study
|
88.9 mmHg
Standard Deviation 9.7
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 10 hours at the end of the study
|
87.5 mmHg
Standard Deviation 10.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 11 hours at the end of the study
|
84.3 mmHg
Standard Deviation 9.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 12 hours at the end of the study
|
82.8 mmHg
Standard Deviation 9.1
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 13 hours at the end of the study
|
80.4 mmHg
Standard Deviation 10.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 14 hours at the end of the study
|
80.1 mmHg
Standard Deviation 13.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 15 hours at the end of the study
|
77.9 mmHg
Standard Deviation 11.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 16 hours at the end of the study
|
77.3 mmHg
Standard Deviation 8.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 17 hours at the end of the study
|
75.5 mmHg
Standard Deviation 11.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 18 hours at the end of the study
|
75.7 mmHg
Standard Deviation 11.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 19 hours at the end of the study
|
76.6 mmHg
Standard Deviation 9.7
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 20 hours at the end of the study
|
79.6 mmHg
Standard Deviation 10.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 21 hours at the end of the study
|
82.4 mmHg
Standard Deviation 10.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 22 hours at the end of the study
|
83.8 mmHg
Standard Deviation 12.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 23 hours at the end of the study
|
87.2 mmHg
Standard Deviation 10.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 24 hours at the end of the study
|
87.0 mmHg
Standard Deviation 12.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 1 hour at baseline
|
157.9 mmHg
Standard Deviation 17.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 2 hours at baseline
|
156.5 mmHg
Standard Deviation 20.1
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 3 hours at baseline
|
158.4 mmHg
Standard Deviation 21.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 4 hours at baseline
|
152.6 mmHg
Standard Deviation 15.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 5 hours at baseline
|
152.1 mmHg
Standard Deviation 21.1
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 6 hours at baseline
|
152.6 mmHg
Standard Deviation 24.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 7 hours at baseline
|
154.6 mmHg
Standard Deviation 23.3
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 8 hours at baseline
|
157.3 mmHg
Standard Deviation 19.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 10 hours at baseline
|
157.6 mmHg
Standard Deviation 20.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 11 hours at baseline
|
153.3 mmHg
Standard Deviation 21.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 12 hours at baseline
|
150.0 mmHg
Standard Deviation 20.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 13 hours at baseline
|
145.8 mmHg
Standard Deviation 22.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 14 hours at baseline
|
146.3 mmHg
Standard Deviation 22.7
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 15 hours at baseline
|
141.9 mmHg
Standard Deviation 23.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 16 hours at baseline
|
142.2 mmHg
Standard Deviation 26.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 17 hours at baseline
|
139.6 mmHg
Standard Deviation 19.1
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 18 hours at baseline
|
137.8 mmHg
Standard Deviation 22.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 19 hours at baseline
|
139.2 mmHg
Standard Deviation 20.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 20 hours at baseline
|
142.2 mmHg
Standard Deviation 21.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 21 hours at baseline
|
143.6 mmHg
Standard Deviation 20.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 22 hours at baseline
|
148.5 mmHg
Standard Deviation 22.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 23 hours at baseline
|
156.6 mmHg
Standard Deviation 18.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 24 hours at baseline
|
158.2 mmHg
Standard Deviation 16.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 1 hour at the end of the study
|
132.8 mmHg
Standard Deviation 15.0
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 2 hours at the end of the study
|
130.2 mmHg
Standard Deviation 15.3
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 3 hours at the end of the study
|
128.3 mmHg
Standard Deviation 17.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 4 hours at the end of the study
|
130.6 mmHg
Standard Deviation 17.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 5 hours at the end of the study
|
128.2 mmHg
Standard Deviation 19.1
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 6 hours at the end of the study
|
128.8 mmHg
Standard Deviation 17.3
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 7 hours at the end of the study
|
125.5 mmHg
Standard Deviation 19.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 8 hours at the end of the study
|
129.7 mmHg
Standard Deviation 15.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 9 hours at the end of the study
|
133.2 mmHg
Standard Deviation 16.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 10 hours at the end of the study
|
131.7 mmHg
Standard Deviation 17.3
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 11 hours at the end of the study
|
130.5 mmHg
Standard Deviation 17.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 12 hours at the end of the study
|
126.6 mmHg
Standard Deviation 15.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 13 hours at the end of the study
|
123.5 mmHg
Standard Deviation 15.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 14 hours at the end of the study
|
124.2 mmHg
Standard Deviation 19.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 15 hours at the end of the study
|
119.1 mmHg
Standard Deviation 14.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 16 hours at the end of the study
|
117.8 mmHg
Standard Deviation 14.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 17 hours at the end of the study
|
116.4 mmHg
Standard Deviation 16.0
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 18 hours at the end of the study
|
116.1 mmHg
Standard Deviation 18.4
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 19 hours at the end of the study
|
118.0 mmHg
Standard Deviation 17.8
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 20 hours at the end of the study
|
121.7 mmHg
Standard Deviation 19.0
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 21 hours at the end of the study
|
126.6 mmHg
Standard Deviation 18.3
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 22 hours at the end of the study
|
129.3 mmHg
Standard Deviation 21.5
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 23 hours at the end of the study
|
132.0 mmHg
Standard Deviation 16.6
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 24 hours at the end of the study
|
133.1 mmHg
Standard Deviation 20.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 1 hour at baseline
|
101.6 mmHg
Standard Deviation 10.2
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP after 20 hours at baseline
|
90.3 mmHg
Standard Deviation 12.9
|
|
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
SBP after 9 hours at baseline
|
161.0 mmHg
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Treated Set (TS) defined as all patients who entered the run-in phase and were treated with T80/A5.
Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events
Outcome measures
| Measure |
T80/A5
n=27 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Treatment Emergent Adverse Events
Patients with any AEs
|
4 Participants
|
|
Treatment Emergent Adverse Events
Patients with severe AEs
|
0 Participants
|
|
Treatment Emergent Adverse Events
Patients with drug-related AEs
|
1 Participants
|
|
Treatment Emergent Adverse Events
Patients with AEs related to laboratory changes
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: TS with non-missing data
Outcome measures
| Measure |
T80/A5
n=27 Participants
Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
|
|---|---|
|
Change From Baseline to End of Study in In-clinic Pulse Rate
|
2.37 beats per minute (bpm)
Standard Deviation 5.95
|
Adverse Events
T80/A5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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