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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017336-40 | EudraCT Number | EudraCT |
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The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.
Study Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| telmisartan/amlodipine | Experimental | start low dose and uptitrate to high dose on the basis of blood pressure goal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan/amlodipine | Drug | start low dose and uptitrate to high dose on the basis of BP goal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. | Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg. | 4 and 8 weeks |
| BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). |
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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 |
|---|---|---|---|---|---|---|
| 1235.33.49010 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||||
| 1235.33.49002 Boehringer Ingelheim Investigational Site |
This was a prospective, single-arm, open-label, uncontrolled, multi-centre, international trial. Whilst 542 patients were enrolled, 502 entered the study. Since one patient refused to take study medication, only 501 patients were treated. The Full analysis set (FAS) consisted of 494 patients and this is the basis of most data presentations.
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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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Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg. |
| Week 12 |
| Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | weeks 4, 8 and 12 |
| Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate | Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12. | weeks 4, 8 and 12 |
| Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure | weeks 4, 8 and 12 |
| DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg. | weeks 4, 8 and 12 |
| Percentage of Patients in Blood Pressure Categories Over Time | BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg. | weeks 4, 8 and 12 |
| DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg | weeks 4, 8 and 12 |
| Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time | weeks 4 and 8 |
| Frankfurt |
| Germany |
| 1235.33.49007 Boehringer Ingelheim Investigational Site | Haag | Germany |
| 1235.33.49003 Boehringer Ingelheim Investigational Site | Heidelberg | Germany |
| 1235.33.49005 Boehringer Ingelheim Investigational Site | Künzing | Germany |
| 1235.33.49008 Boehringer Ingelheim Investigational Site | Nuremberg | Germany |
| 1235.33.49009 Boehringer Ingelheim Investigational Site | Rednitzhembach | Germany |
| 1235.33.49006 Boehringer Ingelheim Investigational Site | Rodgau-Dudenhofen | Germany |
| 1235.33.49004 Boehringer Ingelheim Investigational Site | Unterschneidheim | Germany |
| 1235.33.49001 Boehringer Ingelheim Investigational Site | Westerkappeln | Germany |
| 1235.33.39009 Boehringer Ingelheim Investigational Site | Arezzo | Italy |
| 1235.33.39002 Boehringer Ingelheim Investigational Site | Bologna | Italy |
| 1235.33.39004 Boehringer Ingelheim Investigational Site | Ferrara | Italy |
| 1235.33.39006 Boehringer Ingelheim Investigational Site | L’Aquila | Italy |
| 1235.33.39007 Boehringer Ingelheim Investigational Site | Naples | Italy |
| 1235.33.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 1235.33.39008 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1235.33.39005 Boehringer Ingelheim Investigational Site | Stradella (PV) | Italy |
| 1235.33.52004 Boehringer Ingelheim Investigational Site | Aguascalientes | Mexico |
| 1235.33.52002 Boehringer Ingelheim Investigational Site | Durango | Mexico |
| 1235.33.52001 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico |
| 1235.33.52003 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico |
| 1235.33.52007 Boehringer Ingelheim Investigational Site | Guadalajara | Mexico |
| 1235.33.52006 Boehringer Ingelheim Investigational Site | México | Mexico |
| 1235.33.52009 Boehringer Ingelheim Investigational Site | México | Mexico |
| 1235.33.52008 Boehringer Ingelheim Investigational Site | Monterrey | Mexico |
| 1235.33.31007 Boehringer Ingelheim Investigational Site | 's-Hertogenbosch | Netherlands |
| 1235.33.31009 Boehringer Ingelheim Investigational Site | Almere Stad | Netherlands |
| 1235.33.31005 Boehringer Ingelheim Investigational Site | Beek en Donk | Netherlands |
| 1235.33.31002 Boehringer Ingelheim Investigational Site | Beerzerveld | Netherlands |
| 1235.33.31008 Boehringer Ingelheim Investigational Site | Ermelo | Netherlands |
| 1235.33.31006 Boehringer Ingelheim Investigational Site | Lichtenvoorde | Netherlands |
| 1235.33.31001 Boehringer Ingelheim Investigational Site | Musselkanaal | Netherlands |
| 1235.33.31004 Boehringer Ingelheim Investigational Site | Nijverdal | Netherlands |
| 1235.33.31003 Boehringer Ingelheim Investigational Site | Wildervank | Netherlands |
| 1235.33.48005 Boehringer Ingelheim Investigational Site | Chorzów | Poland |
| 1235.33.48002 Boehringer Ingelheim Investigational Site | Częstochowa | Poland |
| 1235.33.48003 Boehringer Ingelheim Investigational Site | Częstochowa | Poland |
| 1235.33.48010 Boehringer Ingelheim Investigational Site | Dąbrowa Górnicza | Poland |
| 1235.33.48006 Boehringer Ingelheim Investigational Site | Grodzisk Mazowiecki | Poland |
| 1235.33.48013 Boehringer Ingelheim Investigational Site | Oświęcim | Poland |
| 1235.33.48008 Boehringer Ingelheim Investigational Site | Piotrkow Trybunalski | Poland |
| 1235.33.48004 Boehringer Ingelheim Investigational Site | Poznan | Poland |
| 1235.33.48001 Boehringer Ingelheim Investigational Site | Tychy | Poland |
| 1235.33.48009 Boehringer Ingelheim Investigational Site | Tychy | Poland |
| 1235.33.48011 Boehringer Ingelheim Investigational Site | Warsaw | Poland |
| 1235.33.48007 Boehringer Ingelheim Investigational Site | Wroclaw | Poland |
| COMPLETED |
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| NOT COMPLETED |
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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 | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Systolic Blood Pressure (SBP) at time of baseline | Mean | Standard Deviation | mmHg |
| |||||||||||||||||
| Diastolic Blood Pressure (DBP) at time of baseline | Mean | Standard Deviation | mmHg |
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| 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 | Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. | Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg. | Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks |
|
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| |||||||||||||||||||||||||
| Secondary | BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg. | FAS and LOCF | Posted | Number | Number of participants | 4 and 8 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). | Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg. | FAS and LOCF and with at least one post baseline HBPM measurement | Posted | Number | Number of participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | FAS with non-missing data | Posted | Mean | Standard Deviation | mmHg | weeks 4, 8 and 12 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate | Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12. | Treated Set (TS) with non-missing data | Posted | Mean | Standard Deviation | bpm | weeks 4, 8 and 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure | There was no information in the Case Report Form (CRF) | Posted | weeks 4, 8 and 12 |
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| ||||||||||||||||||||||||||||||
| Secondary | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg. | FAS and LOCF | Posted | Number | Number of participants | weeks 4, 8 and 12 |
|
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| Secondary | Percentage of Patients in Blood Pressure Categories Over Time | BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg. | FAS with non-missing data | Posted | Number | Percentage of participants | weeks 4, 8 and 12 |
|
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| Secondary | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg | FAS and LOCF and with at least one post baseline HBPM measurement | Posted | Number | Number of participants | weeks 4, 8 and 12 |
|
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| Secondary | Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time | FAS | Posted | Number | Number of participants | weeks 4 and 8 |
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12 weeks: From drug administration until end of treatment plus one day.
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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 80mg plus Amlodipine 5mg fixed-dose combination | 1 | 501 | 26 | 501 | ||
| EG001 | T80/A10 | Telmisartan 80 mg plus Amlodipine 10 mg once daily | 1 | 232 | 41 | 232 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| 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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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Week 4 |
| |||||
| Week 8 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Morning |
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| Evening |
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| Change at week 4 SBP (N=485) |
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| Change at week 8 SBP (N=487) |
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| Change at week 12 SBP (N=487) |
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| Change at week 4 DBP (N=485) |
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| Change at week 8 DBP (N=487) |
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| Change at week 12 DBP (N=487) |
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| Title | Denominators | Categories |
|---|
| Change at week 4 (N=482) |
| |||||
| Change at week 8 (N=463) |
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| Change at week 12 (N=344) |
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| Week 4 (n=482) |
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| Week 8 (n=284) |
|