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NCT03205137 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03205137
Other study ID # 0502-0612
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date July 11, 2022

Study information
Verified date June 2022
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 11, 2022
Est. primary completion date July 11, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

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 Proportion of days covered of patients treated with single- and double- combination therapy 180 days
Secondary Demographic and clinical characteristics of patients treated with single- and double combination 180 days
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