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

Completed

• Conditions: Hypertension
• Interventions: Drug: T80/A5/H12.5 FDC

• Registration Number: NCT03021265
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Study Start: 2017-01-20
• Primary Completion: 2019-04-11
• Study Completion: 2019-04-11
• Results First Submitted: 2020-04-03
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Results First Posted: 2020-05-12
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 676

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T80/A5/H12.5 FDC	T80/A5/H12.5 FDC	Patients with hypertension

Primary Outcome Measures

Name	Time	Method
Frequency of Patients With Any Suspected Adverse Drug Reactions	from first intake of Micatrio combination tablet until last intake +1 day (week 52)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Clinic Systolic Blood Pressure at Week 52	At baseline and week 52	Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52
Change From Baseline in Clinic Diastolic Blood Pressure at Week 52	At baseline and week 52	Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury \[mmHg\] at Week 52

Trial Locations

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd; 🇯🇵 Tokyo, Japan