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The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan80mg+Amlodipine5mg | Experimental | combination therapy |
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| amlodipine 5 mg | Active Comparator | Monotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan80mg+Amlodipine5mg | Drug | combination therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in DBP After 8 Weeks of Treatment | Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint. | Baseline and 8 weeks |
| Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients | Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in SBP After 8 Weeks of Treatment | Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint. | Baseline and 8 weeks |
| DBP and SBP Control and Response After 8 Weeks of Treatment |
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Inclusion criteria:
Exclusion criteria:
1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1235.29.86001 Boehringer Ingelheim Investigational Site | Beijing | China | ||||
| 1235.29.86004 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24391142 | Derived | Zhu D, Gao P, Holtbruegge W, Huang C. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. J Int Med Res. 2014 Feb;42(1):52-66. doi: 10.1177/0300060513503756. Epub 2014 Jan 3. |
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Whilst there were 324 patients randomised and treated, there were only 314 in the Full analysis set (FAS).
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| ID | Title | Description |
|---|---|---|
| FG000 | A5 Alone | Amlodipine 5mg monotherapy |
| FG001 | T80/A5 | Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| amlodipine 5mg |
| Drug |
monotherapy |
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| Telmisartan80mg+Amlodipine 5mg | Drug | combination therapy |
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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. |
| Baseline and 8 weeks |
| Number 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. | 8 weeks |
| Change From Baseline in DBP After 4 Weeks of Treatment | Seated trough DBP after 4 weeks. | Baseline and 4 weeks |
| Change From Baseline in SBP After 4 Weeks of Treatment | Seated trough SBP after 4 weeks. | Baseline and 4 weeks |
| DBP and SBP Control and Response After 4 Weeks of Treatment | 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. | Baseline and 4 weeks |
| Number of Patients in Blood Pressure Categories at 4 Weeks | 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. | 4 weeks |
| Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. | Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | From drug administration until end of treatment plus one day |
| Beijing |
| China |
| 1235.29.86006 Boehringer Ingelheim Investigational Site | Changchun | China |
| 1235.29.86013 Boehringer Ingelheim Investigational Site | Changsha | China |
| 1235.29.86014 Boehringer Ingelheim Investigational Site | Guangzhou | China |
| 1235.29.86012 Boehringer Ingelheim Investigational Site | Hangzhou | China |
| 1235.29.86002 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1235.29.86009 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1235.29.86010 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1235.29.86011 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1235.29.86007 Boehringer Ingelheim Investigational Site | Shenyang | China |
| 1235.29.86008 Boehringer Ingelheim Investigational Site | Tianjin | China |
| 1235.29.60017 Boehringer Ingelheim Investigational Site | Johor Bahru | Malaysia |
| 1235.29.60016 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia |
| 1235.29.63018 Boehringer Ingelheim Investigational Site | Metro Manila | Philippines |
| 1235.29.63019 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | A5 Alone | Amlodipine 5mg monotherapy |
| BG001 | T80/A5 | Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Diastolic blood pressure (DBP) | Mean | Standard Deviation | mmHg |
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| Systolic blood pressure (SBP) | 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 | Change From Baseline in DBP After 8 Weeks of Treatment | Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint. | Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and 8 weeks |
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| Primary | Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients | Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint. | FAS with LOCF and further restricted to the Chinese subgroup | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and 8 weeks |
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| Secondary | Change From Baseline in SBP After 8 Weeks of Treatment | Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint. | FAS with LOCF | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and 8 weeks |
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| Secondary | DBP and SBP Control and Response After 8 Weeks of Treatment | 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 with LOCF | Posted | Number | Number of participants | Baseline and 8 weeks |
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| Secondary | Number 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 LOCF | Posted | Number | Number of participants | 8 weeks |
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| Secondary | Change From Baseline in DBP After 4 Weeks of Treatment | Seated trough DBP after 4 weeks. | FAS with LOCF | Posted | Mean | Standard Deviation | mmHg | Baseline and 4 weeks |
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| Secondary | Change From Baseline in SBP After 4 Weeks of Treatment | Seated trough SBP after 4 weeks. | FAS with LOCF | Posted | Mean | Standard Deviation | mmHg | Baseline and 4 weeks |
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| Secondary | DBP and SBP Control and Response After 4 Weeks of Treatment | 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 with LOCF | Posted | Number | Number of participants | Baseline and 4 weeks |
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| Secondary | Number of Patients in Blood Pressure Categories at 4 Weeks | 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 LOCF | Posted | Number | Number of participants | 4 weeks |
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| Secondary | Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. | Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | Treated set included patients who were randomised and took at least one dose of the trial medication in the double-blind treatment period. | Posted | Number | participants | From drug administration until end of treatment plus one day |
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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 | A5 Alone | Amlodipine 5 mg one daily | 0 | 164 | 0 | 164 | ||
| EG001 | T80/A5 | Telmisartan 80 mg plus Amlodipine 5 mg once daily | 0 | 160 | 0 | 160 |
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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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