To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension
The Special Drug Use-results Survey on Long-term Use of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed Dose Combination Tablets in Patients With Hypertension
1 other identifier
observational
676
1 country
1
Brief Summary
Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2017
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedStudy Start
First participant enrolled
January 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2019
CompletedResults Posted
Study results publicly available
May 12, 2020
CompletedMay 12, 2020
May 1, 2020
2.2 years
January 12, 2017
April 3, 2020
May 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (2)
Change From Baseline in Clinic Diastolic Blood Pressure at Week 52
At baseline and week 52
Change From Baseline in Clinic Systolic Blood Pressure at Week 52
At baseline and week 52
Study Arms (1)
T80/A5/H12.5 FDC
Patients with hypertension
Interventions
Eligibility Criteria
500
You may qualify if:
- 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
You may not qualify if:
- Patients who are participating/planned to participate in a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nippon Boehringer Ingelheim Co., Ltd
Tokyo, 4570047, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
- STUDY CHAIR
Rie Ikeda, +81364172200
zzCDMJP_PV_PMS@boehringer-ingelheim.com
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2017
First Posted
January 13, 2017
Study Start
January 20, 2017
Primary Completion
April 11, 2019
Study Completion
April 11, 2019
Last Updated
May 12, 2020
Results First Posted
May 12, 2020
Record last verified: 2020-05