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If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly.
In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg, the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg.
Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy. 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 |
|---|---|---|---|
| Telmisartan and amlodipine FDC | Experimental | once a daily |
|
| Telmisartan monotherapy | Active Comparator | once a daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan and amlodipine | Drug | Telmisartan 80 mg and amlodipine 5 mg once a 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 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing | 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 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing | 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 |
|---|---|---|---|---|---|---|
| 1235.36.01 Boehringer Ingelheim Investigational Site | Chuo-ku,Tokyo | Japan | ||||
| 1235.36.04 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan and Amlodipine FDC | |
| FG001 | Telmisartan |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open-label run-in Period |
|
| |||||||||||||||||||||
| Double-blind Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan and Amlodipine FDC | |
| BG001 | Telmisartan | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 8-week open-label run-in period with telmisartan monotherapy, 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 | mmHg | Baseline, 8 weeks |
|
|
From drug administration in the double blind treatment period until 24 hours after the last dosing, up to 63 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 | Telmisartan and Amlodipine FDC |
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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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C548840 | telmisartan amlodipine combination |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Telmisartan | Drug | 80 mg once a daily |
|
| 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 SBP 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 |
| 1235.36.02 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo | Japan |
| 1235.36.03 Boehringer Ingelheim Investigational Site | Suita, Osaka | Japan |
| Number of patients fulfilled |
|
| NOT COMPLETED |
|
|
Total of all reporting groups
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough | Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, 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 | mmHg | Baseline, 8 weeks |
|
|
|
|
| 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 | FAS | Posted | Number | Percentage of participants | 8 weeks |
|
|
|
|
| Secondary | Seated SBP Control Rate at Trough | SBP control rate: The rate of patients with controlled seated SBP 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 |
|
|
|
|
| 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 |
|
|
|
|
| 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 |
|
|
|
|
| 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 |
|
|
|
|
| 0 |
| 87 |
| 5 |
| 87 |
| EG001 | Telmisartan | 0 | 87 | 2 | 87 |
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.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Normal |
|
| High-normal |
|