HypertensionNCT03205137
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
An observational study of Hypertension, run by Boehringer Ingelheim at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- subjects treated with telmisartan/hydrochlorothiazide, Subjects treated with Telmisartan and amlodipine and subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2022to 11 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Japan Medical Information Research Institute (JMIRI), Inc. prescription database is used.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hypertension
- Being tested
- subjects treated with telmisartan/hydrochlorothiazide, Subjects treated with Telmisartan and amlodipine, subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group, subjects treated with telmisartan+amlodipine double pill
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subjects treated with telmisartan/hydrochlorothiazideDrug
Also called MICARDIS, PRITOR, TELMISARTAN
subjects treated with telmisartan/hydrochlorothiazide
Subjects treated with Telmisartan and amlodipineDrug
Also called MICARDIS, PRITOR, TELMISARTAN
Subjects treated with Telmisartan and amlodipine
subjects treated with Telmisartan+hydrochlorothiazide double-pill combination groupDrug
Also called MICARDIS, PRITOR, TELMISARTAN
subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group
subjects treated with telmisartan+amlodipine double pillDrug
Also called MICARDIS, PRITOR, TELMISARTAN
subjects treated with telmisartan+amlodipine double pill
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan and hydrochlorothiazide group | Not described Receives: Drug: subjects treated with telmisartan/hydrochlorothiazide | |
| Telmisartan and amlodipine group | Not described Receives: Drug: Subjects treated with Telmisartan and amlodipine | |
| Telmisartan+hydrochlorothiazide double-pill combination group | Not described Receives: Drug: subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group | |
| telmisartan+amlodipine double-pill combination group | Not described Receives: Drug: subjects treated with telmisartan+amlodipine double pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of days covered of patients treated with single- and double- combination therapy
Measured: 180 days
Secondary outcomes (1)
Demographic and clinical characteristics of patients treated with single- and double combination
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jun 2022 (estimated)
- Primary completion11 Jul 2022 (estimated)
- Study completion11 Jul 2022 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205137
- Sponsor's protocol ID
- 0502-0612
- Status last verified
- Jun 2022
- First submitted
- 29 Jun 2017
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03205137
- Acronym / sponsor ID
- 0502-0612
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 11 Jul 2022 (estimated)
- Study completion
- 11 Jul 2022 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Japan Medical Information Research Institute (JMIRI), Inc. prescription database is used.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subjects treated with telmisartan/hydrochlorothiazideAlso: MICARDIS, PRITOR, TELMISARTANsubjects treated with telmisartan/hydrochlorothiazide | Drug | Telmisartan and hydrochlorothiazide group |
| Subjects treated with Telmisartan and amlodipineAlso: MICARDIS, PRITOR, TELMISARTANSubjects treated with Telmisartan and amlodipine | Drug | Telmisartan and amlodipine group |
| subjects treated with Telmisartan+hydrochlorothiazide double-pill combination groupAlso: MICARDIS, PRITOR, TELMISARTANsubjects treated with Telmisartan+hydrochlorothiazide double-pill combination group | Drug | Telmisartan+hydrochlorothiazide double-pill combination group |
| subjects treated with telmisartan+amlodipine double pillAlso: MICARDIS, PRITOR, TELMISARTANsubjects treated with telmisartan+amlodipine double pill | Drug | telmisartan+amlodipine double-pill combination group |
Primary outcome
Proportion of days covered of patients treated with single- and double- combination therapy
Time frame: 180 days
1 secondary outcome
Demographic and clinical characteristics of patients treated with single- and double combination
Time frame: 180 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Boehringer Ingelheim at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of days covered of patients treated with single- and double- combination therapy (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.