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

June 23, 2022 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 141-6017
        • Nippon Boehringer Ingelheim Co., Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Japan Medical Information Research Institute (JMIRI), Inc. prescription database is used.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of days covered of patients treated with single- and double- combination therapy
Time Frame: 180 days
180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Demographic and clinical characteristics of patients treated with single- and double combination
Time Frame: 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

July 11, 2022

Study Completion (Anticipated)

July 11, 2022

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0502-0612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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