NCT03205137

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
4.9 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

June 29, 2017

Last Update Submit

June 23, 2022

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Proportion of days covered of patients treated with single- and double- combination therapy

    180 days

Secondary Outcomes (1)

  • Demographic and clinical characteristics of patients treated with single- and double combination

    180 days

Study Arms (4)

Telmisartan and hydrochlorothiazide group

Drug: subjects treated with telmisartan/hydrochlorothiazide

Telmisartan and amlodipine group

Drug: Subjects treated with Telmisartan and amlodipine

Telmisartan+hydrochlorothiazide double-pill combination group

Drug: subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group

telmisartan+amlodipine double-pill combination group

Drug: subjects treated with telmisartan+amlodipine double pill

Interventions

subjects treated with telmisartan/hydrochlorothiazideDRUG

subjects treated with telmisartan/hydrochlorothiazide

Also known as: MICARDIS, PRITOR, TELMISARTAN
Telmisartan and hydrochlorothiazide group
Subjects treated with Telmisartan and amlodipineDRUG

Subjects treated with Telmisartan and amlodipine

Also known as: MICARDIS, PRITOR, TELMISARTAN
Telmisartan and amlodipine group
subjects treated with Telmisartan+hydrochlorothiazide double-pill combination groupDRUG

subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group

Also known as: MICARDIS, PRITOR, TELMISARTAN
Telmisartan+hydrochlorothiazide double-pill combination group
subjects treated with telmisartan+amlodipine double pillDRUG

subjects treated with telmisartan+amlodipine double pill

Also known as: MICARDIS, PRITOR, TELMISARTAN
telmisartan+amlodipine double-pill combination group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, 141-6017, Japan

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

TelmisartanHydrochlorothiazideAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesDihydropyridinesPyridinesHeterocyclic Compounds, 1-Ring
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

June 1, 2022

Primary Completion

July 11, 2022

Study Completion

July 11, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

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

Locations

JP(1)