Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT2007-002410-19 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan/amlodipine 40/5 mg fixed combination | Drug | |||
| telmisartan/amlodipine 80/5 mg fixed combination | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Seated Diastolic Blood Pressure (DBP) Control | The number of patients who reach the target DBP of <90mmHg | End of study (34 weeks or last value on treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Seated Systolic Blood Pressure (SBP) Control | The number of patients who reach the target SBP of <140mmHg | End of study (34 weeks or last value on treatment) |
| Change From Baseline in Trough Seated Diastolic Blood Pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1235.7.32004 Boehringer Ingelheim Investigational Site | Aywaille | Belgium | ||||
| 1235.7.32010 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24653513 | Derived | Neldam S, Edwards C, Lang M, Jones R; TEAMSTA-5 and TEAMSTA-10 Investigators. Long-Term Tolerability and Efficacy of Single-Pill Combinations of Telmisartan 40-80 mg Plus Amlodipine 5 or 10 mg in Patients Whose Blood Pressure Was Not Initially Controlled by Amlodipine 5-10 mg: Open-Label, Long-Term Follow-Ups of the TEAMSTA-5 and TEAMSTA-10 Studies. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):65-84. doi: 10.1016/j.curtheres.2012.02.004. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan 40mg and Amlodipine 5mg | |
| FG001 | Telmisartan 80mg and Amlodipine 5mg | |
| FG002 | Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.
| End of study (34 weeks or last value on treatment) |
| Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | The difference between the last available troughs represents the additional reduction in DBP in this study | End of study (34 weeks or last value on treatment) |
| Change From Baseline in Trough Seated Systolic Blood Pressure | Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5. | End of study (34 weeks or last value on treatment) |
| Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | The difference between the last available troughs represents the additional reduction in SBP in this study | End of study (34 weeks or last value on treatment) |
| Trough Seated DBP Response | The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg | End of study (34 weeks or last value on treatment) |
| Trough Seated SBP Response | The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg | End of study (34 weeks or last value on treatment) |
| Trough Blood Pressure (BP) Normality Classes | The number of patients who reach predefined BP categories | End of study (34 weeks or last value on treatment) |
| Time to First Additional Antihypertensive | Time from first intake of medication to first intake of an antihypertensive other than the study drug | At any point during open-label treatment |
| Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment | At any point during open-label treatment |
| Additional Reduction in DBP by Use of Additional Antihypertensive Therapy | Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7 | At any point during open-label treatment |
| Additional Reduction in SBP by Use of Additional Antihypertensive Therapy | Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7 | At any point during open-label treatment |
| Trough DBP Control Pre- and Post- Uptitration | The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration | At any point during open-label treatment |
| Gozée |
| Belgium |
| 1235.7.32008 Boehringer Ingelheim Investigational Site | Linkebeek | Belgium |
| 1235.7.32003 Boehringer Ingelheim Investigational Site | Mol | Belgium |
| 1235.7.32007 Boehringer Ingelheim Investigational Site | Natoye | Belgium |
| 1235.7.32002 Boehringer Ingelheim Investigational Site | Tienen | Belgium |
| 1235.7.32005 Boehringer Ingelheim Investigational Site | Turnhout | Belgium |
| 1235.7.20001 Boehringer Ingelheim Investigational Site | Coquitlam | British Columbia | Canada |
| 1235.7.20011 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1235.7.20007 Boehringer Ingelheim Investigational Site | Bay Roberts | Newfoundland and Labrador | Canada |
| 1235.7.20005 Boehringer Ingelheim Investigational Site | Mount Pearl | Newfoundland and Labrador | Canada |
| 1235.7.20008 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador | Canada |
| 1235.7.20013 Boehringer Ingelheim Investigational Site | Corunna | Ontario | Canada |
| 1235.7.20014 Boehringer Ingelheim Investigational Site | Etobicoke | Ontario | Canada |
| 1235.7.20010 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1235.7.20012 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1235.7.20009 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada |
| 1235.7.20006 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada |
| 1235.7.20003 Boehringer Ingelheim Investigational Site | Sainte-Foy | Quebec | Canada |
| 1235.7.45002 Boehringer Ingelheim Investigational Site | Birkerød | Denmark |
| 1235.7.45005 Boehringer Ingelheim Investigational Site | Haderslev | Denmark |
| 1235.7.45008 Boehringer Ingelheim Investigational Site | Herning | Denmark |
| 1235.7.45009 Boehringer Ingelheim Investigational Site | Hinnerup | Denmark |
| 1235.7.45001 Boehringer Ingelheim Investigational Site | Rødovre Municipality | Denmark |
| 1235.7.45006 Boehringer Ingelheim Investigational Site | Rødovre Municipality | Denmark |
| 1235.7.45003 Boehringer Ingelheim Investigational Site | Vaerløse | Denmark |
| 1235.7.45007 Boehringer Ingelheim Investigational Site | Vildbjerg | Denmark |
| 1235.7.35003 Boehringer Ingelheim Investigational Site | Joensuu | Finland |
| 1235.7.35004 Boehringer Ingelheim Investigational Site | Joensuu | Finland |
| 1235.7.35001 Boehringer Ingelheim Investigational Site | Turku | Finland |
| 1235.7.35002 Boehringer Ingelheim Investigational Site | Turku | Finland |
| 1235.7.3301H Boehringer Ingelheim Investigational Site | Aigrefeuille S/Maine | France |
| 1235.7.3306C Boehringer Ingelheim Investigational Site | Angers | France |
| 1235.7.3309B Boehringer Ingelheim Investigational Site | Angers | France |
| 1235.7.3309C Boehringer Ingelheim Investigational Site | Angers | France |
| 1235.7.3309E Boehringer Ingelheim Investigational Site | Angers | France |
| 1235.7.3309D Boehringer Ingelheim Investigational Site | Avrillé | France |
| 1235.7.3309A Boehringer Ingelheim Investigational Site | Beaucouzé | France |
| 1235.7.3305A Boehringer Ingelheim Investigational Site | Bourg Des Cptes | France |
| 1235.7.3306D Boehringer Ingelheim Investigational Site | Briollay | France |
| 1235.7.3308B Boehringer Ingelheim Investigational Site | Cholet | France |
| 1235.7.3308F Boehringer Ingelheim Investigational Site | Cholet | France |
| 1235.7.3302C Boehringer Ingelheim Investigational Site | Garchizy | France |
| 1235.7.3303C Boehringer Ingelheim Investigational Site | Grandchamps | France |
| 1235.7.3302D Boehringer Ingelheim Investigational Site | Guérigny | France |
| 1235.7.3310A Boehringer Ingelheim Investigational Site | Jarny | France |
| 1235.7.3301L Boehringer Ingelheim Investigational Site | La Chapelle /s Erdre | France |
| 1235.7.3301J Boehringer Ingelheim Investigational Site | La Chapelle-sur-Erdre | France |
| 1235.7.3304A Boehringer Ingelheim Investigational Site | La Fresnais | France |
| 1235.7.3308E Boehringer Ingelheim Investigational Site | La Jubaudière | France |
| 1235.7.3301G Boehringer Ingelheim Investigational Site | La Montagne | France |
| 1235.7.3307D Boehringer Ingelheim Investigational Site | Le Mesnil-en-Vallée | France |
| 1235.7.3301E Boehringer Ingelheim Investigational Site | Le Temple-de-Bretagne | France |
| 1235.7.3309F Boehringer Ingelheim Investigational Site | Les Ponts-de-Cé | France |
| 1235.7.3305B Boehringer Ingelheim Investigational Site | Louvigné Le Bais | France |
| 1235.7.3307E Boehringer Ingelheim Investigational Site | Mouliherne | France |
| 1235.7.3306A Boehringer Ingelheim Investigational Site | Mûrs-Erigné | France |
| 1235.7.3307A Boehringer Ingelheim Investigational Site | Mûrs-Erigné | France |
| 1235.7.3301A Boehringer Ingelheim Investigational Site | Nantes | France |
| 1235.7.3301B Boehringer Ingelheim Investigational Site | Nantes | France |
| 1235.7.3301D Boehringer Ingelheim Investigational Site | Nantes | France |
| 1235.7.3301M Boehringer Ingelheim Investigational Site | Nantes | France |
| 1235.7.3302A Boehringer Ingelheim Investigational Site | Nevers | France |
| 1235.7.3302F Boehringer Ingelheim Investigational Site | Nevers | France |
| 1235.7.3301I Boehringer Ingelheim Investigational Site | Nort-sur-Erdre | France |
| 1235.7.3301C Boehringer Ingelheim Investigational Site | Orvault | France |
| 1235.7.3307F Boehringer Ingelheim Investigational Site | Parçay-les-Pins | France |
| 1235.7.3301F Boehringer Ingelheim Investigational Site | Saint Aubin Les Châteaux | France |
| 1235.7.3306F Boehringer Ingelheim Investigational Site | Saint-Georges-de-Montaigu | France |
| 1235.7.3304B Boehringer Ingelheim Investigational Site | Saint-Ouen-la-Rouërie | France |
| 1235.7.3301N Boehringer Ingelheim Investigational Site | Sautron | France |
| 1235.7.3306B Boehringer Ingelheim Investigational Site | Segré | France |
| 1235.7.3306E Boehringer Ingelheim Investigational Site | Thouars | France |
| 1235.7.3304C Boehringer Ingelheim Investigational Site | Tinténiac | France |
| 1235.7.3308A Boehringer Ingelheim Investigational Site | Vihiers | France |
| 1235.7.31008 Boehringer Ingelheim Investigational Site | Beerzerveld | Netherlands |
| 1235.7.31006 Boehringer Ingelheim Investigational Site | Bennebroek | Netherlands |
| 1235.7.31004 Boehringer Ingelheim Investigational Site | Hoogwoud | Netherlands |
| 1235.7.31003 Boehringer Ingelheim Investigational Site | Musselkanaal | Netherlands |
| 1235.7.31007 Boehringer Ingelheim Investigational Site | Nijverdal | Netherlands |
| 1235.7.31001 Boehringer Ingelheim Investigational Site | Oude Pekela | Netherlands |
| 1235.7.31005 Boehringer Ingelheim Investigational Site | Roelofarendsveen | Netherlands |
| 1235.7.31010 Boehringer Ingelheim Investigational Site | Voerendaal | Netherlands |
| 1235.7.47001 Boehringer Ingelheim Investigational Site | Ålesund | Norway |
| 1235.7.47002 Boehringer Ingelheim Investigational Site | Bergen | Norway |
| 1235.7.47003 Boehringer Ingelheim Investigational Site | Hamar | Norway |
| 1235.7.47004 Boehringer Ingelheim Investigational Site | Oslo | Norway |
| 1235.7.63006 Boehringer Ingelheim Investigational Site | Makati City | Philippines |
| 1235.7.63001 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 1235.7.63002 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 1235.7.63009 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 1235.7.63008 Boehringer Ingelheim Investigational Site | Pasay | Philippines |
| 1235.7.63005 Boehringer Ingelheim Investigational Site | Pasig | Philippines |
| 1235.7.63003 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 1235.7.63007 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 1235.7.27003 Boehringer Ingelheim Investigational Site | Boksburg | South Africa |
| 1235.7.27006 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 1235.7.27009 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 1235.7.27010 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 1235.7.27004 Boehringer Ingelheim Investigational Site | Durban | South Africa |
| 1235.7.27007 Boehringer Ingelheim Investigational Site | Johannesburg | South Africa |
| 1235.7.27008 Boehringer Ingelheim Investigational Site | Johannesburg | South Africa |
| 1235.7.27001 Boehringer Ingelheim Investigational Site | Krugersdorp | South Africa |
| 1235.7.27005 Boehringer Ingelheim Investigational Site | Lenasia | South Africa |
| 1235.7.27002 Boehringer Ingelheim Investigational Site | Pretoria | South Africa |
| 1235.7.82007 Boehringer Ingelheim Investigational Site | Busan | South Korea |
| 1235.7.82001 Boehringer Ingelheim Investigational Site | Daegu | South Korea |
| 1235.7.82006 Boehringer Ingelheim Investigational Site | Daejeon | South Korea |
| 1235.7.82004 Boehringer Ingelheim Investigational Site | Gangwon-Do | South Korea |
| 1235.7.82008 Boehringer Ingelheim Investigational Site | Gwangju | South Korea |
| 1235.7.82002 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1235.7.82003 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1235.7.82005 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1235.7.46002 Boehringer Ingelheim Investigational Site | Gothenburg | Sweden |
| 1235.7.46003 Boehringer Ingelheim Investigational Site | Gothenburg | Sweden |
| 1235.7.46005 Boehringer Ingelheim Investigational Site | Luleå | Sweden |
| 1235.7.46004 Boehringer Ingelheim Investigational Site | Rättvik | Sweden |
| 1235.7.46001 Boehringer Ingelheim Investigational Site | Stockholm | Sweden |
| 1235.7.88605 Boehringer Ingelheim Investigational Site | Changhua | Taiwan |
| 1235.7.88608 Boehringer Ingelheim Investigational Site | Hualien City | Taiwan |
| 1235.7.88601 Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan |
| 1235.7.88603 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| FG003 | Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan 40mg and Amlodipine 5mg | |
| BG001 | Telmisartan 80mg and Amlodipine 5mg | |
| BG002 | Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | |
| BG003 | Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | |
| BG004 | Total | Total of all reporting groups |
| 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 |
|
| 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 | Trough Seated Diastolic Blood Pressure (DBP) Control | The number of patients who reach the target DBP of <90mmHg | The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Number | Participants | End of study (34 weeks or last value on treatment) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Seated Systolic Blood Pressure (SBP) Control | The number of patients who reach the target SBP of <140mmHg | The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Number | Participants | End of study (34 weeks or last value on treatment) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure | Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5. | All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 1235.5) and at least one on treatment BP measurement 20-30 hours post dose | Posted | Least Squares Mean | Standard Error | mmHg | End of study (34 weeks or last value on treatment) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | The difference between the last available troughs represents the additional reduction in DBP in this study | Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement | Posted | Least Squares Mean | Standard Error | mmHg | End of study (34 weeks or last value on treatment) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure | Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5. | Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement | Posted | Least Squares Mean | Standard Error | mmHg | End of study (34 weeks or last value on treatment) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | The difference between the last available troughs represents the additional reduction in SBP in this study | All patients who took at least one dose of study medication, have a trough baseline measurement (Last value on treatment in 1235.5) and at least one on treatment BP measurement 20-30 hours post dose | Posted | Least Squares Mean | Standard Error | mmHg | End of study (34 weeks or last value on treatment) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Seated DBP Response | The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg | The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Number | Participants | End of study (34 weeks or last value on treatment) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Seated SBP Response | The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg | The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Number | Participants | End of study (34 weeks or last value on treatment) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Blood Pressure (BP) Normality Classes | The number of patients who reach predefined BP categories | The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Number | Participants | End of study (34 weeks or last value on treatment) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Additional Antihypertensive | Time from first intake of medication to first intake of an antihypertensive other than the study drug | Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Mean | Standard Deviation | Days | At any point during open-label treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment | Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Number | Participants | At any point during open-label treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Additional Reduction in DBP by Use of Additional Antihypertensive Therapy | Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7 | Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Mean | Standard Deviation | mmHg | At any point during open-label treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Additional Reduction in SBP by Use of Additional Antihypertensive Therapy | Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7 | Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Mean | Standard Deviation | mmHg | At any point during open-label treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough DBP Control Pre- and Post- Uptitration | The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration | Patients from the full analysis set who up-titrated to the higher dose of telmisartan 80 mg and amlodipine 10 mg. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose | Posted | Number | Participants | At any point during open-label treatment |
|
|
From day of first dose until one day after last dose
Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telmisartan 40mg and Amlodipine 5mg | 22 | 976 | 57 | 976 | |||
| EG001 | Telmisartan 80mg and Amlodipine 5mg | 6 | 397 | 45 | 397 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cronary artery disease | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cystic lymphangioma | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Post procedural cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscular disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Perpheral artery aneurysm | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA version 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| No (DBP>=90 mmHg) |
|
| Odds Ratio (OR) |
| 0.31 |
| 95 |
| 0.12 |
| 0.81 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | Odds Ratio (OR) | 0.08 | 95 | 0.06 | 0.13 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | Odds Ratio (OR) | 0.91 | 95 | 0.34 | 2.41 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | Odds Ratio (OR) | 0.25 | 95 | 0.16 | 0.39 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | Odds Ratio (OR) | 0.27 | 95 | 0.10 | 0.72 | No | Superiority or Other |
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|