Hypertension
Conditions
Brief summary
Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in patients with Hypertension
Interventions
DRUGMicamlo
Telmisartan plus Amlodipine T40/A5
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Male and Female patients with hypertension who did not receive of MICAMLO Combination Tablets AP before the start of the study
Exclusion criteria
* Patients with a history of hypersensitivity to any ingredient of Micamlo Combination Tablets AP and dihydropyridine derivatives * Pregnant woman or possibly pregnant woman * Patients with extremely poor bile secretion or patients with serious hepatic disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Drug-related Adverse Events | 12 months | Number of patients with drug-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) | after 1, 2, 3, 6, 12 months | Change from baseline in SBP after 1, 2, 3, 6, 12 months |
| Change From Baseline in Diastolic Blood Pressure (DBP) | after 1, 2, 3, 6, 12 months | Change from baseline in DBP after 1, 2, 3, 6, 12 months |
| Proportion of Patients Who Achieved the Target BP | after 1, 2, 3, 6, 12 months | Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months |
| Proportion of Patients Who Normalised Their BP | after 1, 2, 3, 6, 12 months | Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Hypertension Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration | 1,109 |
| Total | 1,109 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No case report form (CRF) collected | 28 |
Baseline characteristics
| Characteristic | Patients With Hypertension |
|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 514 Participants |
| Sex: Female, Male Male | 595 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,109 |
| serious Total, serious adverse events | 22 / 1,109 |
Outcome results
Primary
Incidence of Drug-related Adverse Events
Number of patients with drug-related adverse events
Time frame: 12 months
Population: Safety set: all patients who were documented to have taken at least one dose of T40/A5 mg FDC except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Hypertension | Incidence of Drug-related Adverse Events | 60 participants |
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP)
Change from baseline in DBP after 1, 2, 3, 6, 12 months
Time frame: after 1, 2, 3, 6, 12 months
Population: Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Hypertension | Change From Baseline in Diastolic Blood Pressure (DBP) | Month 1 | -7.6 mmHg | Standard Deviation 11.7 |
| Patients With Hypertension | Change From Baseline in Diastolic Blood Pressure (DBP) | Month 2 | -8.4 mmHg | Standard Deviation 12.2 |
| Patients With Hypertension | Change From Baseline in Diastolic Blood Pressure (DBP) | Month 3 | -8.2 mmHg | Standard Deviation 12.2 |
| Patients With Hypertension | Change From Baseline in Diastolic Blood Pressure (DBP) | Month 6 | -8.9 mmHg | Standard Deviation 12.7 |
| Patients With Hypertension | Change From Baseline in Diastolic Blood Pressure (DBP) | Month 12 | -9.8 mmHg | Standard Deviation 12.5 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP)
Change from baseline in SBP after 1, 2, 3, 6, 12 months
Time frame: after 1, 2, 3, 6, 12 months
Population: Efficacy set: all patients in the safety set who were labelled by T40/A5 mg Fixed Dose Combination (FDC) and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Hypertension | Change From Baseline in Systolic Blood Pressure (SBP) | Month 1 | -15.9 mmHg | Standard Deviation 18.5 |
| Patients With Hypertension | Change From Baseline in Systolic Blood Pressure (SBP) | Month 2 | -16.5 mmHg | Standard Deviation 18.6 |
| Patients With Hypertension | Change From Baseline in Systolic Blood Pressure (SBP) | Month 3 | -16.7 mmHg | Standard Deviation 19.5 |
| Patients With Hypertension | Change From Baseline in Systolic Blood Pressure (SBP) | Month 6 | -17.7 mmHg | Standard Deviation 20 |
| Patients With Hypertension | Change From Baseline in Systolic Blood Pressure (SBP) | Month 12 | -19.2 mmHg | Standard Deviation 19.7 |
Secondary
Proportion of Patients Who Achieved the Target BP
Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months
Time frame: after 1, 2, 3, 6, 12 months
Population: Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Hypertension | Proportion of Patients Who Achieved the Target BP | Month 1 | 54.2 Percentage of patients (target BP) |
| Patients With Hypertension | Proportion of Patients Who Achieved the Target BP | Month 2 | 57.8 Percentage of patients (target BP) |
| Patients With Hypertension | Proportion of Patients Who Achieved the Target BP | Month 3 | 58.8 Percentage of patients (target BP) |
| Patients With Hypertension | Proportion of Patients Who Achieved the Target BP | Month 6 | 62.4 Percentage of patients (target BP) |
| Patients With Hypertension | Proportion of Patients Who Achieved the Target BP | Month 12 | 66.5 Percentage of patients (target BP) |
Secondary
Proportion of Patients Who Normalised Their BP
Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months
Time frame: after 1, 2, 3, 6, 12 months
Population: Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Hypertension | Proportion of Patients Who Normalised Their BP | Month 1 | 61.3 Percentage of patients (normalised BP) |
| Patients With Hypertension | Proportion of Patients Who Normalised Their BP | Month 2 | 66.3 Percentage of patients (normalised BP) |
| Patients With Hypertension | Proportion of Patients Who Normalised Their BP | Month 3 | 67.2 Percentage of patients (normalised BP) |
| Patients With Hypertension | Proportion of Patients Who Normalised Their BP | Month 6 | 70.4 Percentage of patients (normalised BP) |
| Patients With Hypertension | Proportion of Patients Who Normalised Their BP | Month 12 | 73.7 Percentage of patients (normalised BP) |