Hypertension
Conditions
Brief summary
The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.
Interventions
Sponsors
Astellas Pharma Inc
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Hypertensive patients who have never taken Micombi Tablets.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | Week 52 | The number of patient with any AEs, patients with drug-related AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) | Week 0 and Week 52 | SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated. |
| Diastolic Blood Pressure (DBP) | Week 0 and Week 52 | DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated. |
| Target Blood Pressure Achievement Rate | Week 52 | The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for \>= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient. |
| Blood Pressure Normalised Rate | Week 52 | The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009 |
Countries
Japan
Participant flow
Recruitment details
A total of 1452 patients were enrolled. Of these patients, the CRFs of 9 patients were uncollected by reason of institution, and the 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey.
Participants by arm
| Arm | Count |
|---|---|
| Combination Tablet AP Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg | 1,070 |
| Combination Tablet BP Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg | 355 |
| Total | 1,425 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 75 | 22 |
| Overall Study | Lack of Efficacy | 22 | 35 |
| Overall Study | Lost to Follow-up | 83 | 35 |
| Overall Study | Others | 17 | 11 |
| Overall Study | Physician Decision | 74 | 9 |
Baseline characteristics
| Characteristic | Combination Tablet AP | Combination Tablet BP | Total |
|---|---|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 12 | 69.8 years STANDARD_DEVIATION 12.5 | 68.9 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 570 Participants | 186 Participants | 756 Participants |
| Sex: Female, Male Male | 500 Participants | 169 Participants | 669 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,070 | 0 / 355 | 0 / 1,425 |
| serious Total, serious adverse events | 25 / 1,070 | 12 / 355 | 37 / 1,425 |
Outcome results
Primary
Incidence of Adverse Events (AEs)
The number of patient with any AEs, patients with drug-related AEs
Time frame: Week 52
Population: The all treated patients, 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination Tablet AP | Incidence of Adverse Events (AEs) | patient with any AEs | 221 Patients |
| Combination Tablet AP | Incidence of Adverse Events (AEs) | patients with drug-related AEs | 154 Patients |
| Combination Tablet BP | Incidence of Adverse Events (AEs) | patient with any AEs | 72 Patients |
| Combination Tablet BP | Incidence of Adverse Events (AEs) | patients with drug-related AEs | 46 Patients |
| Total | Incidence of Adverse Events (AEs) | patient with any AEs | 293 Patients |
| Total | Incidence of Adverse Events (AEs) | patients with drug-related AEs | 200 Patients |
Secondary
Blood Pressure Normalised Rate
The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009
Time frame: Week 52
Population: The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Tablet AP | Blood Pressure Normalised Rate | 70.7 percentage of participants |
| Combination Tablet BP | Blood Pressure Normalised Rate | 61.1 percentage of participants |
| Total | Blood Pressure Normalised Rate | 68.3 percentage of participants |
Secondary
Diastolic Blood Pressure (DBP)
DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.
Time frame: Week 0 and Week 52
Population: The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination Tablet AP | Diastolic Blood Pressure (DBP) | Week 0 | 84.7 mmHg | Standard Deviation 13 |
| Combination Tablet AP | Diastolic Blood Pressure (DBP) | Week 52 | 75.2 mmHg | Standard Deviation 10.9 |
| Combination Tablet AP | Diastolic Blood Pressure (DBP) | Change from Week 0 to Week 52 | -9.5 mmHg | Standard Deviation 11.6 |
| Combination Tablet BP | Diastolic Blood Pressure (DBP) | Week 52 | 75.5 mmHg | Standard Deviation 11.2 |
| Combination Tablet BP | Diastolic Blood Pressure (DBP) | Week 0 | 84.6 mmHg | Standard Deviation 12.8 |
| Combination Tablet BP | Diastolic Blood Pressure (DBP) | Change from Week 0 to Week 52 | -9.1 mmHg | Standard Deviation 13.9 |
| Total | Diastolic Blood Pressure (DBP) | Week 52 | 75.3 mmHg | Standard Deviation 11 |
| Total | Diastolic Blood Pressure (DBP) | Change from Week 0 to Week 52 | -9.4 mmHg | Standard Deviation 12.2 |
| Total | Diastolic Blood Pressure (DBP) | Week 0 | 84.7 mmHg | Standard Deviation 13 |
Secondary
Systolic Blood Pressure (SBP)
SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.
Time frame: Week 0 and Week 52
Population: The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination Tablet AP | Systolic Blood Pressure (SBP) | Week 52 | 132.2 mmHg | Standard Deviation 15.1 |
| Combination Tablet AP | Systolic Blood Pressure (SBP) | Week 0 | 152.9 mmHg | Standard Deviation 18.3 |
| Combination Tablet AP | Systolic Blood Pressure (SBP) | Change from Week 0 to Week 52 | -20.7 mmHg | Standard Deviation 18.8 |
| Combination Tablet BP | Systolic Blood Pressure (SBP) | Week 52 | 134.7 mmHg | Standard Deviation 15.5 |
| Combination Tablet BP | Systolic Blood Pressure (SBP) | Week 0 | 155.4 mmHg | Standard Deviation 18.7 |
| Combination Tablet BP | Systolic Blood Pressure (SBP) | Change from Week 0 to Week 52 | -20.7 mmHg | Standard Deviation 21.5 |
| Total | Systolic Blood Pressure (SBP) | Week 0 | 153.5 mmHg | Standard Deviation 18.4 |
| Total | Systolic Blood Pressure (SBP) | Change from Week 0 to Week 52 | -20.7 mmHg | Standard Deviation 19.5 |
| Total | Systolic Blood Pressure (SBP) | Week 52 | 132.8 mmHg | Standard Deviation 15.2 |
Secondary
Target Blood Pressure Achievement Rate
The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for \>= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.
Time frame: Week 52
Population: The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Tablet AP | Target Blood Pressure Achievement Rate | 52.9 Percentage of patients |
| Combination Tablet BP | Target Blood Pressure Achievement Rate | 43.2 Percentage of patients |
| Total | Target Blood Pressure Achievement Rate | 50.5 Percentage of patients |