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Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.
In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients.
Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80mg telmisartan and 5mg amlodipine FDC | Experimental | once daily |
|
| 40mg telmisartan and 5mg amlodipine FDC | Active Comparator | once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40 mg telmisartan | Drug | once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing | Reference baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing | Reference baseline, 8 weeks |
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Inclusion criteria:
Essential hypertensive patients
Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1235.37.01 Boehringer Ingelheim Investigational Site | Chuo-ku,Tokyo | Japan | ||||
| 1235.37.07 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 80 mg Telmisartan and 5 mg Amlodipine FDC | |
| FG001 | 40 mg Telmisartan and 5 mg Amlodipine FDC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 5 mg amlodipine |
| Drug |
once daily |
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| 5 mg amlodipine | Drug | once daily |
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| 80 mg telmisartan | Drug | once daily |
|
| Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined | Reference baseline, 8 weeks |
| Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined | Reference baseline, 8 weeks |
| Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP | Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined | Pseudo-baseline, 14 weeks |
| Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP | Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined | Pseudo-baseline, 14 weeks |
| Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined | Reference baseline, 8 weeks |
| Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined | Reference baseline, 8 weeks |
| Seated DBP Control Rate at Trough | DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks |
| Seated SBP Control Rate at Trough | SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks |
| Seated DBP Response Rate at Trough | DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks |
| Seated SBP Response Rate at Trough | SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks |
| Seated Blood Pressure (BP) Normalisation at Trough | Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing | 8 weeks |
| Hiroshima, Hiroshima |
| Japan |
| 1235.37.08 Boehringer Ingelheim Investigational Site | Itoshima, Fukuoka | Japan |
| 1235.37.02 Boehringer Ingelheim Investigational Site | Katsushika-ku, Tokyo | Japan |
| 1235.37.05 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1235.37.03 Boehringer Ingelheim Investigational Site | Ota-ku, Tokyo | Japan |
| 1235.37.06 Boehringer Ingelheim Investigational Site | Suita, Osaka | Japan |
| 1235.37.04 Boehringer Ingelheim Investigational Site | Yokohama, Kanagawa | Japan |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 80 mg Telmisartan and 5 mg Amlodipine FDC | |
| BG001 | 40 mg Telmisartan and 5 mg Amlodipine FDC | |
| 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 | year |
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| 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 the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing | Full analysis set (FAS) | Posted | Least Squares Mean | Standard Error | mm Hg | Reference baseline, 8 weeks |
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| Secondary | Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing | FAS | Posted | Least Squares Mean | Standard Error | mm Hg | Reference baseline, 8 weeks |
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| Secondary | Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined | ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements | Posted | Least Squares Mean | Standard Error | mm Hg | Reference baseline, 8 weeks |
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| Secondary | Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined | ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements | Posted | Least Squares Mean | Standard Error | mm Hg | Reference baseline, 8 weeks |
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| Secondary | Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP | Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined | ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements | Posted | Least Squares Mean | Standard Error | mm Hg | Pseudo-baseline, 14 weeks |
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| Secondary | Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP | Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined | ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements | Posted | Least Squares Mean | Standard Error | mm Hg | Pseudo-baseline, 14 weeks |
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| Secondary | Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined | ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements | Posted | Mean | Standard Deviation | mm Hg | Reference baseline, 8 weeks |
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| Secondary | Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM | Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined | ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements | Posted | Mean | Standard Deviation | mm Hg | Reference baseline, 8 weeks |
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| Secondary | Seated DBP Control Rate at Trough | DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing | Patients included in FAS and with seated DBP >=90 mmHg at reference baseline | Posted | Number | percentage of participants | 8 weeks |
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| Secondary | Seated SBP Control Rate at Trough | SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing | Patients included in FAS and with seated SBP >=140 mmHg at reference baseline | Posted | Number | percentage of participants | 8 weeks |
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| Secondary | Seated DBP Response Rate at Trough | DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing | FAS | Posted | Number | percentage of participants | 8 weeks |
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| Secondary | Seated SBP Response Rate at Trough | SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing | FAS | Posted | Number | percentage of participants | 8 weeks |
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| Secondary | Seated Blood Pressure (BP) Normalisation at Trough | Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing | FAS | Posted | Number | participants | 8 weeks |
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From first drug administration in the double-blind treatment period until 24 hours after the last dose, up to 69 days
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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 | 80 mg Telmisartan and 5 mg Amlodipine FDC | 1 | 112 | 6 | 112 | |||
| EG001 | 40 mg Telmisartan and 5 mg Amlodipine FDC | 1 | 113 | 6 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral artery occlusion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | 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 |
|---|---|
| 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 |
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