To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021265
• Other study ID #: 1348.6
• Status: Completed
• Start date: January 20, 2017
• Est. completion date: April 11, 2019

Study information

• Verified date: May 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: April 11, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• T80/A5/H12.5 FDC
Drug

Locations

Country	Name	City	State
Japan	Nippon Boehringer Ingelheim Co., Ltd	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	from first intake of Micatrio combination tablet until last intake +1 day (week 52)
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	At baseline and week 52
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	At baseline and week 52