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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03205137

Collaborator

(none)

Enrollment

Location

1.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	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

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jul 11, 2022

Anticipated Study Completion Date :

Jul 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Telmisartan and hydrochlorothiazide group	Drug: subjects treated with telmisartan/hydrochlorothiazide subjects treated with telmisartan/hydrochlorothiazide Other Names: MICARDIS, PRITOR, TELMISARTAN
Telmisartan and amlodipine group	Drug: Subjects treated with Telmisartan and amlodipine Subjects treated with Telmisartan and amlodipine Other Names: MICARDIS, PRITOR, TELMISARTAN
Telmisartan+hydrochlorothiazide double-pill combination group	Drug: subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group Other Names: MICARDIS, PRITOR, TELMISARTAN
telmisartan+amlodipine double-pill combination group	Drug: subjects treated with telmisartan+amlodipine double pill subjects treated with telmisartan+amlodipine double pill Other Names: MICARDIS, PRITOR, TELMISARTAN

Outcome Measures

Primary Outcome Measures

Proportion of days covered of patients treated with single- and double- combination therapy [180 days]

Secondary Outcome Measures

Demographic and clinical characteristics of patients treated with single- and double combination [180 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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