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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eligible hypertension patient | Experimental | Patients will be given placebo for 2 weeks for wash-out, then qualified patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan+amlodipine fixed dose combination | Drug | after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
| Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1235.31.86001 Boehringer Ingelheim Investigational Site | Shanghai | China |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | T80/A5 | Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | T80/A5 | Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T80/A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C548840 | telmisartan amlodipine combination |
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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. |
| 8 weeks |
| Change From Baseline to End of Study in DBP and SBP | Manually measured in-clinic DBP and SBP | 8 weeks |
| 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 | 0 and 8 weeks |
| Treatment Emergent Adverse Events | Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events | 8 weeks |
| Change From Baseline to End of Study in In-clinic Pulse Rate | 8 weeks |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Mean 24-hour mean Diastolic blood pressure (DBP) | Mean | Standard Deviation | mmHg |
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| Mean 24-hour mean Systolic blood pressure (SBP) | Mean | Standard Deviation | mmHg |
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| 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 | FAS | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
|
| 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. | FAS | Posted | Median | Full Range | Ratio | 8 weeks |
|
|
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| Secondary | Change From Baseline to End of Study in DBP and SBP | Manually measured in-clinic DBP and SBP | FAS | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
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| 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 | FAS | Posted | Mean | Standard Deviation | mmHg | 0 and 8 weeks |
|
|
|
| Secondary | Treatment Emergent Adverse Events | Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events | Treated Set (TS) defined as all patients who entered the run-in phase and were treated with T80/A5. | Posted | Number | Participants | 8 weeks |
|
|
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| Secondary | Change From Baseline to End of Study in In-clinic Pulse Rate | TS with non-missing data | Posted | Mean | Standard Deviation | beats per minute (bpm) | 8 weeks |
|
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|
| 0 |
| 27 |
| 0 |
| 27 |
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.
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| DBP Change from baseline after 4 hours |
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| DBP Change from baseline after 5 hours |
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| DBP Change from baseline after 6 hours |
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| DBP Change from baseline after 7 hours |
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| DBP Change from baseline after 8 hours |
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| DBP Change from baseline after 9 hours |
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| DBP Change from baseline after 10 hours |
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| DBP Change from baseline after 11 hours |
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| DBP Change from baseline after 12 hours |
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| DBP Change from baseline after 13 hours |
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| DBP Change from baseline after 14 hours |
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| DBP Change from baseline after 15 hours |
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| DBP Change from baseline after 16 hours |
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| DBP Change from baseline after 17 hours |
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| DBP Change from baseline after 18 hours |
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| DBP Change from baseline after 19 hours |
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| DBP Change from baseline after 20 hours |
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| DBP Change from baseline after 21 hours |
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| DBP Change from baseline after 22 hours |
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| DBP Change from baseline after 23 hours |
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| DBP Change from baseline after 24 hour |
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| SBP Change from baseline after 1 hour |
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| SBP Change from baseline after 2 hours |
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| SBP Change from baseline after 3 hours |
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| SBP Change from baseline after 4 hours |
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| SBP Change from baseline after 5 hours |
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| SBP Change from baseline after 6 hours |
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| SBP Change from baseline after 7 hours |
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| SBP Change from baseline after 8 hours |
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| SBP Change from baseline after 9 hours |
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| SBP Change from baseline after 10 hours |
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| SBP Change from baseline after 11 hours |
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| SBP Change from baseline after 12 hours |
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| SBP Change from baseline after 13 hours |
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| SBP Change from baseline after 14 hours |
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| SBP Change from baseline after 15 hours |
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| SBP Change from baseline after 16 hours |
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| SBP Change from baseline after 17 hours |
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| SBP Change from baseline after 18 hours |
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| SBP Change from baseline after 19 hours |
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| SBP Change from baseline after 20 hours |
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| SBP Change from baseline after 21 hours |
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| SBP Change from baseline after 22 hours |
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| SBP Change from baseline after 23 hours |
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| SBP Change from baseline after 24 hour |
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| SBP: Change from baseline to 2 weeks |
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| SBP: Change from baseline to 4 weeks |
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| SBP: Change from baseline to 8 weeks |
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| DBP after 4 hours at baseline |
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| DBP after 5 hours at baseline |
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| DBP after 6 hours at baseline |
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| DBP after 7 hours at baseline |
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| DBP after 8 hours at baseline |
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| DBP after 9 hours at baseline |
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| DBP after 10 hours at baseline |
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| DBP after 11 hours at baseline |
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| DBP after 12 hours at baseline |
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| DBP after 13 hours at baseline |
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| DBP after 14 hours at baseline |
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| DBP after 15 hours at baseline |
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| DBP after 16 hours at baseline |
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| DBP after 17 hours at baseline |
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| DBP after 18 hours at baseline |
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| DBP after 19 hours at baseline |
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| DBP after 20 hours at baseline |
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| DBP after 21 hours at baseline |
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| DBP after 22 hours at baseline |
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| DBP after 23 hours at baseline |
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| DBP after 24 hours at baseline |
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| DBP after 1 hour at the end of the study |
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| DBP after 2 hours at the end of the study |
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| DBP after 3 hours at the end of the study |
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| DBP after 4 hours at the end of the study |
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| DBP after 5 hours at the end of the study |
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| DBP after 6 hours at the end of the study |
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| DBP after 7 hours at the end of the study |
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| DBP after 8 hours at the end of the study |
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| DBP after 9 hours at the end of the study |
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| DBP after 10 hours at the end of the study |
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| DBP after 11 hours at the end of the study |
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| DBP after 12 hours at the end of the study |
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| DBP after 13 hours at the end of the study |
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| DBP after 14 hours at the end of the study |
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| DBP after 15 hours at the end of the study |
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| DBP after 16 hours at the end of the study |
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| DBP after 17 hours at the end of the study |
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| DBP after 18 hours at the end of the study |
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| DBP after 19 hours at the end of the study |
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| DBP after 20 hours at the end of the study |
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| DBP after 21 hours at the end of the study |
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| DBP after 22 hours at the end of the study |
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| DBP after 23 hours at the end of the study |
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| DBP after 24 hours at the end of the study |
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| SBP after 1 hour at baseline |
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| SBP after 2 hours at baseline |
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| SBP after 3 hours at baseline |
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| SBP after 4 hours at baseline |
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| SBP after 5 hours at baseline |
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| SBP after 6 hours at baseline |
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| SBP after 7 hours at baseline |
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| SBP after 8 hours at baseline |
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| SBP after 9 hours at baseline |
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| SBP after 10 hours at baseline |
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| SBP after 11 hours at baseline |
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| SBP after 12 hours at baseline |
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| SBP after 13 hours at baseline |
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| SBP after 14 hours at baseline |
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| SBP after 15 hours at baseline |
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| SBP after 16 hours at baseline |
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| SBP after 17 hours at baseline |
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| SBP after 18 hours at baseline |
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| SBP after 19 hours at baseline |
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| SBP after 20 hours at baseline |
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| SBP after 21 hours at baseline |
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| SBP after 22 hours at baseline |
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| SBP after 23 hours at baseline |
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| SBP after 24 hours at baseline |
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| SBP after 1 hour at the end of the study |
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| SBP after 2 hours at the end of the study |
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| SBP after 3 hours at the end of the study |
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| SBP after 4 hours at the end of the study |
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| SBP after 5 hours at the end of the study |
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| SBP after 6 hours at the end of the study |
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| SBP after 7 hours at the end of the study |
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| SBP after 8 hours at the end of the study |
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| SBP after 9 hours at the end of the study |
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| SBP after 10 hours at the end of the study |
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| SBP after 11 hours at the end of the study |
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| SBP after 12 hours at the end of the study |
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| SBP after 13 hours at the end of the study |
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| SBP after 14 hours at the end of the study |
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| SBP after 15 hours at the end of the study |
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| SBP after 16 hours at the end of the study |
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| SBP after 17 hours at the end of the study |
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| SBP after 18 hours at the end of the study |
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| SBP after 19 hours at the end of the study |
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| SBP after 20 hours at the end of the study |
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| SBP after 21 hours at the end of the study |
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| SBP after 22 hours at the end of the study |
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| SBP after 23 hours at the end of the study |
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| SBP after 24 hours at the end of the study |
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| Title |
|---|
| Measurements |
|---|
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| Patients with AEs related to laboratory changes |
|