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To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan+amlodipine | Drug | |||
| amlodipine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) | The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. | Baseline and 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing) | The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. | Baseline and 8 Weeks |
| Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
Taking four or more anti-hypertensive medications
Secondary hypertension
Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit 3.
Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
History of myocardial infarction or cardiac surgery within last 6 months
History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
History of unstable angina within last 3 months
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
History of stroke or transient ischemic attack within last 6 months
History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy
Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
Hepatic and/or renal dysfunction
Diagnosed biliary atresia or cholestasis
Hyperkalemia
Dehydration
Sodium deficiency
Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs)
Patients who cannot change to the restricted administration and dosage during study period
Pre-menopausal women who meet any one of the following 1 - 3:
Drug or alcohol dependency
Complication of malignant tumour or a disease requiring immunosuppressants
Compliance of < 80% or > 120% during the run-in period
Receiving any investigational therapy within 3 months
Judged to be inappropriate by the investigator or the sub-investigator
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1235.13.037 Boehringer Ingelheim Investigational Site | Azumino, Nagano | Japan | ||||
| 1235.13.023 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | T40/A5 tablet, oral, once daily in the morning |
| FG001 | Amlodipine 5 mg Monotherapy | A5 capsule, oral, once daily in the morning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake |
| 8 weeks |
| Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) | Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake | 8 weeks |
| Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) | Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks | 8 weeks |
| Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks | Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline) | 8 weeks |
| Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) | Optimal, normal, high normal blood pressure were defined as follows:
| 8 weeks |
| Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | First administration of randomised treatment to 24 hours post last dose of randomised treatment |
| Higashiosaka, Osaka |
| Japan |
| 1235.13.021 Boehringer Ingelheim Investigational Site | Itabashi-ku, Tokyo | Japan |
| 1235.13.014 Boehringer Ingelheim Investigational Site | Kashihara, Osaka | Japan |
| 1235.13.038 Boehringer Ingelheim Investigational Site | Kitaazumi-gun, Nagano | Japan |
| 1235.13.009 Boehringer Ingelheim Investigational Site | Kiyose, Tokyo | Japan |
| 1235.13.041 Boehringer Ingelheim Investigational Site | Kobe, Hyogo | Japan |
| 1235.13.035 Boehringer Ingelheim Investigational Site | Komoro, Nagano | Japan |
| 1235.13.003 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | Japan |
| 1235.13.004 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | Japan |
| 1235.13.027 Boehringer Ingelheim Investigational Site | Koriyama, Fukushima | Japan |
| 1235.13.007 Boehringer Ingelheim Investigational Site | Koshigaya, Saitama, | Japan |
| 1235.13.008 Boehringer Ingelheim Investigational Site | Koto-ku, Tokyo | Japan |
| 1235.13.005 Boehringer Ingelheim Investigational Site | Matsudo, Chiba | Japan |
| 1235.13.026 Boehringer Ingelheim Investigational Site | Mito, Ibaraki | Japan |
| 1235.13.013 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 1235.13.016 Boehringer Ingelheim Investigational Site | Okayama, Okayama, | Japan |
| 1235.13.040 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1235.13.025 Boehringer Ingelheim Investigational Site | Saitama, Saitama | Japan |
| 1235.13.001 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1235.13.024 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1235.13.028 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1235.13.030 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1235.13.031 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1235.13.033 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1235.13.034 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1235.13.002 Boehringer Ingelheim Investigational Site | Sendai, Miyagi | Japan |
| 1235.13.018 Boehringer Ingelheim Investigational Site | Sendai, Miyagi | Japan |
| 1235.13.019 Boehringer Ingelheim Investigational Site | Sendai, Miyagi | Japan |
| 1235.13.036 Boehringer Ingelheim Investigational Site | Shimoina-gun, Nagano | Japan |
| 1235.13.042 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo | Japan |
| 1235.13.010 Boehringer Ingelheim Investigational Site | Shinjyuku-ku, Tokyo | Japan |
| 1235.13.011 Boehringer Ingelheim Investigational Site | Shinjyuku-ku,Tokyo | Japan |
| 1235.13.022 Boehringer Ingelheim Investigational Site | Shizuoka, Shizuoka | Japan |
| 1235.13.015 Boehringer Ingelheim Investigational Site | Suita, Osaka, | Japan |
| 1235.13.017 Boehringer Ingelheim Investigational Site | Takamatsu, Kagawa | Japan |
| 1235.13.029 Boehringer Ingelheim Investigational Site | Takamatsu, Kagawa | Japan |
| 1235.13.032 Boehringer Ingelheim Investigational Site | Takamatsu, Kagawa | Japan |
| 1235.13.012 Boehringer Ingelheim Investigational Site | Takaoka, Toyama | Japan |
| 1235.13.039 Boehringer Ingelheim Investigational Site | Takaoka,Toyama | Japan |
| 1235.13.020 Boehringer Ingelheim Investigational Site | Tsuchiura, Ibaraki | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | T40/A5 tablet, oral, once daily in the morning |
| BG001 | Amlodipine 5 mg Monotherapy | A5 capsule, oral, once daily in the morning |
| BG002 | 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 | Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) | The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | Posted | Mean | Standard Error | mmHg | Baseline and 8 Weeks |
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| Secondary | Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing) | The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | Posted | Mean | Standard Error | mmHg | Baseline and 8 Weeks |
|
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| Secondary | Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) | Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | Posted | Number | percentage of patients | 8 weeks |
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| Secondary | Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) | Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | Posted | Number | percentage of patients | 8 weeks |
|
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| Secondary | Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) | Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | Posted | Number | percentage of patients | 8 weeks |
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| Secondary | Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks | Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline) | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | Posted | Number | percentage of patients | 8 weeks |
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| Secondary | Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) | Optimal, normal, high normal blood pressure were defined as follows:
| Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | Posted | Number | percentage of patients | 8 weeks |
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| Secondary | Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | Treated set: Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or A5 during the double-blind treatment period. | Posted | Number | participants | First administration of randomised treatment to 24 hours post last dose of randomised treatment |
|
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First administration of randomised treatment to 24 hours post last dose of randomised treatment
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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 | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | T40/A5 tablet, oral, once daily in the morning | 1 | 269 | 25 | 269 | ||
| EG001 | Amlodipine 5 mg Monotherapy | A5 capsule, oral, once daily in the morning | 2 | 262 | 34 | 262 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Cerebellar infarction | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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 |
|---|---|
| C548840 | telmisartan amlodipine combination |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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