Hypertension
Conditions
Brief summary
Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension
Detailed description
Non-interventional study based on newly collected data. The study will consist of a baseline visit and follow-up visits at Week 4, 8, 12, 24, 36 and 52 for patients who have newly initiated Micatrio® Combination Tablets. The patients will be followed up until discontinuation of Micatrio® Combination Tablets treatment or the end of study. All patients administrated Micatrio® Combination Tablets after the launch at the sites contracted with the sponsor will be registered.
Interventions
DRUGT80/A5/H12.5 FDC
Drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are prescribed with Micatrio® Combination Tablets by the discretion of investigators based on the Japanese package insert * Patients who have never been treated with Micatrio® Combination Tablets before enrolment
Exclusion criteria
Patients who are participating/planned to participate in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Patients With Any Suspected Adverse Drug Reactions | from first intake of Micatrio combination tablet until last intake +1 day (week 52) | An Adverse drug reaction (ADR) is defined as an AE for which either the investigator or the sponsor (or both) assess the causal relationship to Micatrio Combination Tablets as related. The frequency of patients with any suspected ADR is presented as total number of participants with an ADR reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinic Diastolic Blood Pressure at Week 52 | At baseline and week 52 | Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury \[mmHg\] at Week 52 |
| Change From Baseline in Clinic Systolic Blood Pressure at Week 52 | At baseline and week 52 | Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52 |
Countries
Japan
Participant flow
Recruitment details
This was an observational study based on newly collected data under real-world practice in participants with hypertension in Japan.
Pre-assignment details
Non-randomized, post marketing surveillance, a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline concomitant drug in use) were defined for participant enrollment. Participants were enrolled from February 2017 to January 2018 (The first existed in Jan, system opened with delay on Feb).
Participants by arm
| Arm | Count |
|---|---|
| Micatrio® Combination Tablets Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg | 672 |
| Total | 672 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 29 |
| Overall Study | Improved | 17 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 67 |
| Overall Study | No reason given | 2 |
| Overall Study | No visit since the first visit | 4 |
Baseline characteristics
| Characteristic | Micatrio® Combination Tablets | — |
|---|---|---|
| Age, Continuous | 68.8 years STANDARD_DEVIATION 13.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 269 Participants | — |
| Sex: Female, Male Male | 403 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 672 |
| other Total, other adverse events | 0 / 672 |
| serious Total, serious adverse events | 20 / 672 |
Outcome results
Primary
Frequency of Patients With Any Suspected Adverse Drug Reactions
An Adverse drug reaction (ADR) is defined as an AE for which either the investigator or the sponsor (or both) assess the causal relationship to Micatrio Combination Tablets as related. The frequency of patients with any suspected ADR is presented as total number of participants with an ADR reported.
Time frame: from first intake of Micatrio combination tablet until last intake +1 day (week 52)
Population: Safety Set: This patient set included all patients who did not have important protocol violations regarding safety and regulatory issues.~4 patients were excluded because of missing visits after baseline.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Micatrio® Combination Tablets | Frequency of Patients With Any Suspected Adverse Drug Reactions | 32 Participants |
Secondary
Change From Baseline in Clinic Diastolic Blood Pressure at Week 52
Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury \[mmHg\] at Week 52
Time frame: At baseline and week 52
Population: The effectiveness set included all patients in safety set with approved indication and had effectiveness information and no effectiveness related protocol violation. Only participants with data in baseline and week 52 were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micatrio® Combination Tablets | Change From Baseline in Clinic Diastolic Blood Pressure at Week 52 | -2.0 millimeters of mercury (mmHG) | Standard Deviation 10 |
Secondary
Change From Baseline in Clinic Systolic Blood Pressure at Week 52
Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52
Time frame: At baseline and week 52
Population: The effectiveness set included all patients in safety set with approved indication and had effectiveness information and no effectiveness related protocol violation. Only participants with data in baseline and week 52 were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micatrio® Combination Tablets | Change From Baseline in Clinic Systolic Blood Pressure at Week 52 | -2.6 millimeters of mercury (mmHG) | Standard Deviation 15.4 |