Trial Outcomes & Findings for To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension (NCT NCT03021265)
NCT ID: NCT03021265
Last Updated: 2020-05-12
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
676 participants
Primary outcome timeframe
from first intake of Micatrio combination tablet until last intake +1 day (week 52)
Results posted on
2020-05-12
Participant Flow
This was an observational study based on newly collected data under real-world practice in participants with hypertension in 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).
Participant milestones
| Measure |
Micatrio® Combination Tablets
Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
|
|---|---|
|
Overall Study
STARTED
|
676
|
|
Overall Study
COMPLETED
|
554
|
|
Overall Study
NOT COMPLETED
|
122
|
Reasons for withdrawal
| Measure |
Micatrio® Combination Tablets
Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
|
|---|---|
|
Overall Study
Adverse Event
|
29
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Improved
|
17
|
|
Overall Study
Lost to Follow-up
|
67
|
|
Overall Study
No reason given
|
2
|
|
Overall Study
No visit since the first visit
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Micatrio® Combination Tablets
n=672 Participants
Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
|
|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 13.2 • n=672 Participants
|
|
Sex: Female, Male
Female
|
269 Participants
n=672 Participants
|
|
Sex: Female, Male
Male
|
403 Participants
n=672 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Micatrio® Combination Tablets
n=672 Participants
Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
|
|---|---|
|
Frequency of Patients With Any Suspected Adverse Drug Reactions
|
32 Participants
|
SECONDARY outcome
Timeframe: At baseline and week 52Population: 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.
Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury \[mmHg\] at Week 52
Outcome measures
| Measure |
Micatrio® Combination Tablets
n=654 Participants
Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
|
|---|---|
|
Change From Baseline in Clinic Diastolic Blood Pressure at Week 52
|
-2.0 millimeters of mercury (mmHG)
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: At baseline and week 52Population: 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.
Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52
Outcome measures
| Measure |
Micatrio® Combination Tablets
n=654 Participants
Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
|
|---|---|
|
Change From Baseline in Clinic Systolic Blood Pressure at Week 52
|
-2.6 millimeters of mercury (mmHG)
Standard Deviation 15.4
|
Adverse Events
Micatrio
Serious events: 20 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Micatrio
n=672 participants at risk
Micatrio® Combination Tablets, telmisartan 80 milligram (mg)/amlodipine 5 mg/hydrochlorothiazide 12.5 mg
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
0.15%
1/672 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.15%
1/672 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.15%
1/672 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.15%
1/672 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.15%
1/672 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.15%
1/672 • 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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.15%
1/672 • 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.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.15%
1/672 • 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.
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
2/672 • 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.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.15%
1/672 • 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.
|
|
Nervous system disorders
Coma
|
0.15%
1/672 • 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.
|
|
Nervous system disorders
Brain injury
|
0.15%
1/672 • 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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.15%
1/672 • 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.
|
|
Cardiac disorders
Angina unstable
|
0.15%
1/672 • 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.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.15%
1/672 • 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.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.15%
1/672 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.15%
1/672 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.15%
1/672 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.15%
1/672 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.15%
1/672 • 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.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.15%
1/672 • 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.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.15%
1/672 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.15%
1/672 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.15%
1/672 • 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.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.15%
1/672 • 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.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.15%
1/672 • 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.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.15%
1/672 • 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.
|
|
Investigations
Blood pressure decreased
|
0.15%
1/672 • 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.
|
|
Surgical and medical procedures
Transcatheter aortic valve implantation
|
0.15%
1/672 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
2/672 • 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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.15%
1/672 • 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.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.15%
1/672 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.15%
1/672 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place