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This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan+amlodipine+HCTZ | Experimental | telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet |
|
| Telmisartan+amlodipine | Active Comparator | telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan + amlodipine | Drug | FDC tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period. | Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints. | baseline and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period. | Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints. |
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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 |
|---|---|---|---|---|---|---|
| 1348.1.015 Boehringer Ingelheim Investigational Site | Atsubetsu-ku,Sapporo,Hokkaido | Japan | ||||
| 1348.1.006 Boehringer Ingelheim Investigational Site |
This study is randomised, double-blind, active-control, parallel-group comparison
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| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan and Amlodipine+HCTZ | Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet. |
| FG001 | Telmisartan+Amlodipine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| hydrochlorothiazide |
| Drug |
tablet |
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| Telmisartan + amlodipine | Drug | FDC tablet |
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| Placebo | Drug | placebo matching hydrochlorothiazide tablet |
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| baseline and week 8 |
| The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period | Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed. | baseline and week 8 |
| Bunkyo-ku, Tokyo |
| Japan |
| 1348.1.002 Boehringer Ingelheim Investigational Site | Chiyoda-ku, Tokyo | Japan |
| 1348.1.005 Boehringer Ingelheim Investigational Site | Chiyoda-ku, Tokyo | Japan |
| 1348.1.031 Boehringer Ingelheim Investigational Site | Chiyoda-ku, Tokyo | Japan |
| 1348.1.030 Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo | Japan |
| 1348.1.033 Boehringer Ingelheim Investigational Site | Chuo-ku, Tokyo | Japan |
| 1348.1.016 Boehringer Ingelheim Investigational Site | Chuo-ku,Sapporo,Hokkaido | Japan |
| 1348.1.021 Boehringer Ingelheim Investigational Site | Chuo-ku,Tokyo | Japan |
| 1348.1.024 Boehringer Ingelheim Investigational Site | Itabashi-ku, Tokyo | Japan |
| 1348.1.028 Boehringer Ingelheim Investigational Site | Itoshima, Fukuoka | Japan |
| 1348.1.027 Boehringer Ingelheim Investigational Site | Katsushika-ku, Tokyo | Japan |
| 1348.1.001 Boehringer Ingelheim Investigational Site | Kishiwada, Osaka | Japan |
| 1348.1.009 Boehringer Ingelheim Investigational Site | Kita-ku, Osaka | Japan |
| 1348.1.029 Boehringer Ingelheim Investigational Site | Kita-ku, Osaka | Japan |
| 1348.1.014 Boehringer Ingelheim Investigational Site | Kiyose,Tokyo | Japan |
| 1348.1.003 Boehringer Ingelheim Investigational Site | Koto-ku, Tokyo | Japan |
| 1348.1.022 Boehringer Ingelheim Investigational Site | Mihama-ku, Chiba, Chiba | Japan |
| 1348.1.004 Boehringer Ingelheim Investigational Site | Miyagino-ku, Sendai, Miyagi | Japan |
| 1348.1.017 Boehringer Ingelheim Investigational Site | Moriya, Ibaraki | Japan |
| 1348.1.013 Boehringer Ingelheim Investigational Site | Naka-ku,Yokohama,Kanagawa | Japan |
| 1348.1.018 Boehringer Ingelheim Investigational Site | Nishi-ku, Fukuoka, Fukuoka | Japan |
| 1348.1.007 Boehringer Ingelheim Investigational Site | Okinawa, Okinawa | Japan |
| 1348.1.020 Boehringer Ingelheim Investigational Site | Sakaide, Kagawa | Japan |
| 1348.1.025 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1348.1.026 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1348.1.008 Boehringer Ingelheim Investigational Site | Suita, Osaka | Japan |
| 1348.1.032 Boehringer Ingelheim Investigational Site | Suita, Osaka | Japan |
| 1348.1.019 Boehringer Ingelheim Investigational Site | Takamatsu, Kagawa | Japan |
| 1348.1.023 Boehringer Ingelheim Investigational Site | Toshima-ku, Tokyo | Japan |
Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet |
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Treated Set (TS): The treated set consisted of all patients who were randomised to the double-blind period and took at least 1 dose of the randomised treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan and Amlodipine+HCTZ | Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet. |
| BG001 | Telmisartan+Amlodipine | Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet |
| 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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| 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 Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period. | Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints. | Full analysis set (FAS): This analysis set was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period. | Posted | Mean | Standard Error | mmHg | baseline and week 8 |
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| Secondary | Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period. | Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints. | FAS | Posted | Mean | Standard Error | mmHg | baseline and week 8 |
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| Secondary | The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period | Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | baseline and week 8 |
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From first drug administration until 24 hours after the last drug administration, up to 71 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+HCTZ | Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet. | 0 | 149 | 36 | 149 | ||
| EG001 | Telmisartan+Amlodipine | Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet | 0 | 160 | 14 | 160 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 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 |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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