Hypertension
Conditions
Brief summary
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.
Detailed description
Study Design: PMS Observational study
Interventions
DRUGTwynsta tablet
Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10
Sponsors
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Adverse Events | Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg) | 8±2 weeks | Percentage of subjects who had achieved normal blood pressure (SBP/DBP \< 140/90 millimeters of mercury (mmHg))is presented |
| Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg) | 8±2 weeks | Percentage of subjects who achieved DBP response (defined as mean sitting DBP \< 90 mmHg or a reduction of over 10 mmHg) is presented |
| Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg) | 8±2 weeks | Percentage of subjects who achieved SBP response (defined as mean sitting SBP \< 140 mmHg or a reduction of over 10 mmHg) is presented |
| Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg. | 8±2 weeks | Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP \< 130/80 mmHg is presented |
Countries
South Korea
Participant flow
Recruitment details
Case report forms of subjects were retrieved from 34 investigators at 26 institutions
Pre-assignment details
The study initiated on Dec 21, 2010, but the local health authority fixed the study period as August 19, 2010 to August 18, 2016
Participants by arm
| Arm | Count |
|---|---|
| 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. | 610 |
| Total | 610 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Deviation with contract date | 7 |
| Overall Study | Duplicate subject | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Protocol Violation | 51 |
Baseline characteristics
| Characteristic | Twynsta® Tablets |
|---|---|
| Age, Continuous | 61.96 years STANDARD_DEVIATION 12.43 |
| Sex: Female, Male Female | 271 Participants |
| Sex: Female, Male Male | 339 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 610 |
| serious Total, serious adverse events | 3 / 610 |
Outcome results
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)
Time frame: Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)
Population: Subjects data collected during the surveillance period (19 Aug 2010 to 18 Aug 2016).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Twynsta® Tablets | Percentage of Subjects With Adverse Events | Short term surveillance | 3.28 percentage of participants |
| Twynsta® Tablets | Percentage of Subjects With Adverse Events | Long term surveillance | 3.80 percentage of participants |
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
Time frame: 8±2 weeks
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twynsta® Tablets | Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg) | 89.45 percentage of participants |
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
Time frame: 8±2 weeks
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twynsta® Tablets | Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg) | 87.76 percentage of participants |
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
Time frame: 8±2 weeks
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twynsta® Tablets | Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg) | 74.95 percentage of participants |
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
Time frame: 8±2 weeks
Population: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twynsta® Tablets | Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg. | 39.53 percentage of participants |