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Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T80/A5/H12.5 FDC | Patients with hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T80/A5/H12.5 FDC | Drug | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from first intake of Micatrio combination tablet until last intake +1 day (week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At baseline and week 52 |
| Change From Baseline in Clinic Systolic Blood Pressure at Week 52 |
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Inclusion criteria:
Exclusion criteria:
Patients who are participating/planned to participate in a clinical trial
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500
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Rie Ikeda, +81364172200 | zzCDMJP_PV_PMS@boehringer-ingelheim.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd | Tokyo | 4570047 | Japan |
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).
This was an observational study based on newly collected data under real-world practice in participants with hypertension in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Micatrio® Combination Tablets | Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set: This patient set included all patients who did not have important protocol violations regarding safety and regulatory issues.
4 patients were exclude because of missing visit after baseline
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| ID | Title | Description |
|---|---|---|
| BG000 | Micatrio® Combination Tablets | Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | from first intake of Micatrio combination tablet until last intake +1 day (week 52) |
|
from first intake of Micatrio combination tablet until last intake +1 day (week 52)
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.
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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 | Micatrio | Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 16, 2015 | Apr 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2019 | Apr 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52 |
| At baseline and week 52 |
| Lost to Follow-up |
|
| No reason given |
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| No visit since the first visit |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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 | 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. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHG) | At baseline and week 52 |
|
|
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| 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 | 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. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHG) | At baseline and week 52 |
|
|
|
| 2 |
| 672 |
| 20 |
| 672 |
| 0 |
| 672 |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperparathyroidism primary | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Coma | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Brain injury | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Transcatheter aortic valve implantation | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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