Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice

Withdrawn

• Conditions: Hypertension
• Interventions: Drug: subjects treated with telmisartan/hydrochlorothiazide; Drug: Subjects treated with Telmisartan and amlodipine; Drug: subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group; Drug: subjects treated with telmisartan+amlodipine double pill

• Registration Number: NCT03205137
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this study is to compare the medication adherence measured by PDC of patients with FDC or double-pill combination therapy in real-world Japanese therapeutic practice.The further objective of this study is how much influence the background of patients to the adherence.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-29
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Status Verified: 2022-06
• Study Start: 2022-06-01
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-28
• Primary Completion: 2022-07-11
• Study Completion: 2022-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with hypertension
• Patients must have their first prescription (defined as index date*) for telmisartan and hydrochlorothiazide or Micombi® between 01/07/2010 and 28/09/2010
• Patients must have their first prescription (defined as index date*) for telmisartan and amlodipine or Micamlo® between 10/12/2010 and 09/03/2011
• Patients must have at least 180 days follow up verified by the presence of prescription record

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Exclusion Criteria

• Patients who were under 40 years old at the time of enrolment
• Patients who prescribed the study drugs less than 90 days during a follow up period of 180 days
• Patients whose visits are less than 2 times during a follow up period of 180 days

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Telmisartan and hydrochlorothiazide group	subjects treated with telmisartan/hydrochlorothiazide	-
Telmisartan and amlodipine group	Subjects treated with Telmisartan and amlodipine	-
Telmisartan+hydrochlorothiazide double-pill combination group	subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group	-
telmisartan+amlodipine double-pill combination group	subjects treated with telmisartan+amlodipine double pill	-

Primary Outcome Measures

Name	Time	Method
Proportion of days covered of patients treated with single- and double- combination therapy	180 days

Secondary Outcome Measures

Name	Time	Method
Demographic and clinical characteristics of patients treated with single- and double combination	180 days

Trial Locations

Locations (1)

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