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This is a prospective, observational, open-label, multi-center study, which will provide detailed information about the safety and efficacy of Twynsta tablets in Korean hypertensive patients requiring combination therapy. This will present a convenient treatment option for hypertension in Korean patients.
Study Design:
PMS Observational study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with essential hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Twynsta tablet | Drug | Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Adverse Events | Percentage of subjects with adverse events is presented. Results are reported for short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks) | Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg) | Percentage of subjects who had achieved normal blood pressure (SBP/DBP < 140/90 millimeters of mercury (mmHg))is presented | 8±2 weeks |
| Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg) |
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Inclusion criteria:
No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.
Exclusion criteria:
No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.
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Korean patients wtih essential hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NISND Center | One Or Multiple Sites | South Korea |
The study initiated on Dec 21, 2010, but the local health authority fixed the study period as August 19, 2010 to August 18, 2016
Case report forms of subjects were retrieved from 34 investigators at 26 institutions
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| ID | Title | Description |
|---|---|---|
| FG000 | Twynsta® Tablets | Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Percentage of subjects who achieved DBP response (defined as mean sitting DBP < 90 mmHg or a reduction of over 10 mmHg) is presented |
| 8±2 weeks |
| Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg) | Percentage of subjects who achieved SBP response (defined as mean sitting SBP < 140 mmHg or a reduction of over 10 mmHg) is presented | 8±2 weeks |
| Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg. | Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP < 130/80 mmHg is presented | 8±2 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Subjects data collected during the surveillance period (19 Aug 2010 to 18 Aug 2016).
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| ID | Title | Description |
|---|---|---|
| BG000 | Twynsta® Tablets | Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine. |
| 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 |
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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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg) | Percentage of subjects who had achieved normal blood pressure (SBP/DBP < 140/90 millimeters of mercury (mmHg))is presented | An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days) | Posted | Number | 95% Confidence Interval | percentage of participants | 8±2 weeks |
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| Primary | Percentage of Subjects With Adverse Events | Percentage of subjects with adverse events is presented. Results are reported for short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks) | Subjects data collected during the surveillance period (19 Aug 2010 to 18 Aug 2016). | Posted | Number | 95% Confidence Interval | percentage of participants | Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks) |
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| Secondary | Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg) | Percentage of subjects who achieved DBP response (defined as mean sitting DBP < 90 mmHg or a reduction of over 10 mmHg) is presented | An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days) | Posted | Number | 95% Confidence Interval | percentage of participants | 8±2 weeks |
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| Secondary | Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg) | Percentage of subjects who achieved SBP response (defined as mean sitting SBP < 140 mmHg or a reduction of over 10 mmHg) is presented | An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days) | Posted | Number | 95% Confidence Interval | percentage of participants | 8±2 weeks |
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| Secondary | Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg. | Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP < 130/80 mmHg is presented | An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days) | Posted | Number | 95% Confidence Interval | percentage of participants | 8±2 weeks |
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Adverse events collected during the surveillance period (19 Aug 2010 to 18 Aug 2016); up to 313 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 | Twynsta® Tablets | Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine. | 3 | 610 | 0 | 610 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | 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 |
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