Hypertension
Conditions
Brief summary
The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension
Interventions
DRUGtelmisartan+amlodipine fixed dose combination
after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged at least 18 years at the date of signing the consent form 2. For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry 3. 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring
Exclusion criteria
1. mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg 2. any clinically significant hepatic impairment 3. severe renal impairment 4. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant 5. current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped 6. other conditions or situations that could put potential participants at unacceptable risk due to participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean | 8 weeks | ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment | 8 weeks | 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. |
| Change From Baseline to End of Study in DBP and SBP | 8 weeks | Manually measured in-clinic DBP and SBP |
| Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing | 8 weeks | 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 |
| Treatment Emergent Adverse Events | 8 weeks | Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events |
| Change From Baseline to End of Study in In-clinic Pulse Rate | 8 weeks | — |
| ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing | 0 and 8 weeks | DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment |
Countries
China
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| T80/A5 Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | T80/A5 |
|---|---|
| Age, Continuous | 52.0 Years STANDARD_DEVIATION 8.7 |
| Mean 24-hour mean Diastolic blood pressure (DBP) | 95.79 mmHg STANDARD_DEVIATION 7.74 |
| Mean 24-hour mean Systolic blood pressure (SBP) | 150.24 mmHg STANDARD_DEVIATION 17.3 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean
ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5 | 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 |
| T80/A5 | 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
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing
DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment
Time frame: 0 and 8 weeks
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
Secondary
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing
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
Time frame: 8 weeks
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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
Change From Baseline to End of Study in DBP and SBP
Manually measured in-clinic DBP and SBP
Time frame: 8 weeks
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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 |
| T80/A5 | 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
Change From Baseline to End of Study in In-clinic Pulse Rate
Time frame: 8 weeks
Population: TS with non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T80/A5 | Change From Baseline to End of Study in In-clinic Pulse Rate | 2.37 beats per minute (bpm) | Standard Deviation 5.95 |
Secondary
Treatment Emergent Adverse Events
Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events
Time frame: 8 weeks
Population: Treated Set (TS) defined as all patients who entered the run-in phase and were treated with T80/A5.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80/A5 | Treatment Emergent Adverse Events | Patients with severe AEs | 0 Participants |
| T80/A5 | Treatment Emergent Adverse Events | Patients with any AEs | 4 Participants |
| T80/A5 | Treatment Emergent Adverse Events | Patients with drug-related AEs | 1 Participants |
| T80/A5 | Treatment Emergent Adverse Events | Patients with AEs related to laboratory changes | 0 Participants |
Secondary
Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment
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.
Time frame: 8 weeks
Population: FAS
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| T80/A5 | Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment | DBP T/P ratio (N=23) | 1.13 Ratio |
| T80/A5 | Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment | SBP T/P ratio (N=25) | 0.98 Ratio |