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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT 2007-002421-68 |
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The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fixed dose combination of telmisartan+amlodipine | Drug | |||
| amlodipine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Seated Diastolic Blood Pressure | Change from baseline to the end of study in trough DBP | Baseline and end of study (8 weeks or last value on treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough Seated Systolic Blood Pressure | Change from baseline to the end of study in trough SBP | Baseline and end of study (8 weeks or last value on treatment) |
| Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) |
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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 |
|---|---|---|---|---|---|---|
| 1235.6.61003 Boehringer Ingelheim Investigational Site | Gosford | New South Wales | Australia | |||
| 1235.6.61004 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine 10mg | |
| FG001 | Telmisartan 40mg and Amlodipine 10mg | |
| FG002 | Telmisartan 80mg and Amlodipine 10mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The number of patients who reach the target DBP of <90mmHg |
| End of study (8 weeks or last value on treatment) |
| Trough Seated Diastolic Blood Pressure <80 mmHg | The number of patients who reach the target DBP of <80mmHg | End of study (8 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 (8 weeks or last value on treatment) |
| Trough Seated SBP Control | The number of patients who reach the target SBP of <140mmHg | End of study (8 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 (8 weeks or last value on treatment) |
| Trough Seated BP Normality Classes | The number of patients who reach predefined BP categories | End of study (8 weeks or last value on treatment) |
| Oedema Incidence Rate | The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years) | During randomised treatment period |
| Peripheral Oedema Incidence Rate | The number of cases of peripheral oedema (expressed as number of cases/100 patient-years) | During randomised treatment period |
| Liverpool |
| New South Wales |
| Australia |
| 1235.6.61002 Boehringer Ingelheim Investigational Site | Kippa-Ring | Queensland | Australia |
| 1235.6.61001 Boehringer Ingelheim Investigational Site | Milton | Queensland | Australia |
| 1235.6.61005 Boehringer Ingelheim Investigational Site | Elizabeth Vale | South Australia | Australia |
| 1235.6.43007 Boehringer Ingelheim Investigational Site | Eggenburg | Austria |
| 1235.6.43006 Boehringer Ingelheim Investigational Site | Hainburg A.d. Donau | Austria |
| 1235.6.43005 Boehringer Ingelheim Investigational Site | Hartberg | Austria |
| 1235.6.43001 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1235.6.43002 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1235.6.43003 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1235.6.35912 Boehringer Ingelheim Investigational Site | Burgas | Bulgaria |
| 1235.6.35902 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 1235.6.35903 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 1235.6.35904 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 1235.6.35905 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 1235.6.35906 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 1235.6.35907 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 1235.6.35910 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 1235.6.35911 Boehringer Ingelheim Investigational Site | Sofia | Bulgaria |
| 1235.6.35901 Boehringer Ingelheim Investigational Site | Varna | Bulgaria |
| 1235.6.42002 Boehringer Ingelheim Investigational Site | Benátky nad Jizerou | Czechia |
| 1235.6.42006 Boehringer Ingelheim Investigational Site | Brno | Czechia |
| 1235.6.42001 Boehringer Ingelheim Investigational Site | Pilsen | Czechia |
| 1235.6.42003 Boehringer Ingelheim Investigational Site | Prague | Czechia |
| 1235.6.42004 Boehringer Ingelheim Investigational Site | Příbram | Czechia |
| 1235.6.42005 Boehringer Ingelheim Investigational Site | Slaný | Czechia |
| 1235.6.42007 Boehringer Ingelheim Investigational Site | Strakonice | Czechia |
| 1235.6.35304 Wilmer Road | Birr | Ireland |
| 1235.6.35305 Dr. Ger McLaughlin | Carrigtohill | Ireland |
| 1235.6.35302 Slaney Medical Centre | Enniscorthy | Ireland |
| 1235.6.35303 Gorey Medical Centre, Coral House, | Gorey | Ireland |
| 1235.6.35306 The Red House Surgery | Mallow | Ireland |
| 1235.6.35301 Boehringer Ingelheim Investigational Site | New Ross | Ireland |
| 1235.6.39002 Boehringer Ingelheim Investigational Site | Broni (pv) | Italy |
| 1235.6.39006 Boehringer Ingelheim Investigational Site | Coppito (AQ) | Italy |
| 1235.6.39001 Boehringer Ingelheim Investigational Site | Ferrara | Italy |
| 1235.6.64003 Boehringer Ingelheim Investigational Site | Dunedin | New Zealand |
| 1235.6.64002 Boehringer Ingelheim Investigational Site | Otahuhu, Auckland | New Zealand |
| 1235.6.64001 Boehringer Ingelheim Investigational Site | Tauranga | New Zealand |
| 1235.6.70004 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1235.6.70005 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1235.6.70006 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1235.6.70007 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1235.6.70008 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1235.6.70009 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1235.6.70010 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1235.6.70011 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1235.6.70012 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1235.6.42103 Boehringer Ingelheim Investigational Site | Dolný Kubín | Slovakia |
| 1235.6.42106 Boehringer Ingelheim Investigational Site | Kralovsky Chmlec | Slovakia |
| 1235.6.42104 Boehringer Ingelheim Investigational Site | Liptovský Mikuláš | Slovakia |
| 1235.6.42102 Boehringer Ingelheim Investigational Site | Považská Bystrica | Slovakia |
| 1235.6.42105 Boehringer Ingelheim Investigational Site | Prešov | Slovakia |
| 1235.6.42101 Boehringer Ingelheim Investigational Site | Trenčín | Slovakia |
| 1235.6.42107 Boehringer Ingelheim Investigational Site | Vráble | Slovakia |
| 1235.6.34008 Hospital Municipal de Badalona | Badalona | Spain |
| 1235.6.34009 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1235.6.34001 Hospital Gral de Jerez de la Frontera | Jerez de La Frontera (Cádiz) | Spain |
| 1235.6.34006 C.A.P. Mossen Cinto Verdaguer | L'Hospitalet de Llobregat (Barcelona) | Spain |
| 1235.6.34003 Hospital Doce de Octubre | Madrid | Spain |
| 1235.6.34004 Hospital La Princesa | Madrid | Spain |
| 1235.6.34011 Boehringer Ingelheim Investigational Site | Santa Coloma de Gramanet | Spain |
| 1235.6.41005 Boehringer Ingelheim Investigational Site | Gordola | Switzerland |
| 1235.6.90004 Boehringer Ingelheim Investigational Site | Erzurum | Turkey (Türkiye) |
| 1235.6.90003 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 1235.6.90005 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 1235.6.90001 Boehringer Ingelheim Investigational Site | Izmir | Turkey (Türkiye) |
| 1235.6.38010 Boehringer Ingelheim Investigational Site | Dnipro | Ukraine |
| 1235.6.38001 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1235.6.38003 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1235.6.38008 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1235.6.38011 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1235.6.38004 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1235.6.38006 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1235.6.38012 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1235.6.38013 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1235.6.38002 Boehringer Ingelheim Investigational Site | Lviv | Ukraine |
| 1235.6.38005 Boehringer Ingelheim Investigational Site | Odesa | Ukraine |
| 1235.6.38009 Boehringer Ingelheim Investigational Site | Odesa | Ukraine |
| 1235.6.38007 Boehringer Ingelheim Investigational Site | Zaporizhzhya | Ukraine |
| 1235.6.44010 Boehringer Ingelheim Investigational Site | Bexhill-on-Sea | United Kingdom |
| 1235.6.44008 Boehringer Ingelheim Investigational Site | Blackpool | United Kingdom |
| 1235.6.44016 Boehringer Ingelheim Investigational Site | Blackpool | United Kingdom |
| 1235.6.44011 Boehringer Ingelheim Investigational Site | Burbage, Hinkley | United Kingdom |
| 1235.6.44007 Boehringer Ingelheim Investigational Site | Chestfield, Whitstable | United Kingdom |
| 1235.6.44005 Boehringer Ingelheim Investigational Site | Chorley | United Kingdom |
| 1235.6.44002 Boehringer Ingelheim Investigational Site | Edgbaston, Birmingham | United Kingdom |
| 1235.6.44009 Boehringer Ingelheim Investigational Site | Ely | United Kingdom |
| 1235.6.44001 Boehringer Ingelheim Investigational Site | Fowey | United Kingdom |
| 1235.6.44003 Boehringer Ingelheim Investigational Site | Glasgow | United Kingdom |
| 1235.6.44012 Boehringer Ingelheim Investigational Site | Penzance | United Kingdom |
| 1235.6.44013 Boehringer Ingelheim Investigational Site | Plymouth | United Kingdom |
| 1235.6.44004 Boehringer Ingelheim Investigational Site | Reading | United Kingdom |
| 1235.6.44015 Boehringer Ingelheim Investigational Site | Saint Stephen, Saint Austell | United Kingdom |
| 1235.6.44014 Boehringer Ingelheim Investigational Site | Saltash | United Kingdom |
| 1235.6.44006 Boehringer Ingelheim Investigational Site | Whitstable | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amlodipine 10mg | |
| BG001 | Telmisartan 40mg and Amlodipine 10mg | |
| BG002 | Telmisartan 80mg and Amlodipine 10mg | |
| BG003 | 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 |
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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 | Change From Baseline in Trough Seated Diastolic Blood Pressure | Change from baseline to the end of study in trough DBP | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and end of study (8 weeks or last value on treatment) |
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| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure | Change from baseline to the end of study in trough SBP | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and end of study (8 weeks or last value on treatment) |
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| Secondary | Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) | The number of patients who reach the target DBP of <90mmHg | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Posted | Number | Participants | End of study (8 weeks or last value on treatment) |
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| Secondary | Trough Seated Diastolic Blood Pressure <80 mmHg | The number of patients who reach the target DBP of <80mmHg | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Posted | Number | Participants | End of study (8 weeks or last value on treatment) |
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| Secondary | Trough Seated DBP Response | The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Posted | Number | Participants | End of study (8 weeks or last value on treatment) |
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| Secondary | Trough Seated SBP Control | The number of patients who reach the target SBP of <140mmHg | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Posted | Number | Participants | End of study (8 weeks or last value on treatment) |
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| Secondary | Trough Seated SBP Response | The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Posted | Number | Participants | End of study (8 weeks or last value on treatment) |
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| Secondary | Trough Seated BP Normality Classes | The number of patients who reach predefined BP categories | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Posted | Number | Participants | End of study (8 weeks or last value on treatment) |
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| Secondary | Oedema Incidence Rate | The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years) | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Posted | Number | Number of patients/100 patient-years | During randomised treatment period |
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| Secondary | Peripheral Oedema Incidence Rate | The number of cases of peripheral oedema (expressed as number of cases/100 patient-years) | Posted | Number | Number of cases/100 patient-years | During randomised treatment period |
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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 | Amlodipine 10mg | 1 | 22 | |||||
| EG001 | Telmisartan 40mg and Amlodipine 10mg | 3 | 21 | |||||
| EG002 | Telmisartan 80mg and Amlodipine 10mg | 0 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral oedema | General disorders | MedDRA 11.1 | Systematic Assessment |
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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 |
|---|---|
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Testing that the combination treatments are superior to monotherapy A10. The number of patients in the treatment arms ensure the tests have over 90% power. | ANCOVA | Adjusted for baseline and country effect | <0.0001 | Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10. | Least Squares Mean Difference | -2.85 | Standard Error of the Mean | 0.51 | 95 | -3.86 | -1.84 | No | Superiority or Other |
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