HypertensionNCT02092025
Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
An observational study of Hypertension, run by Takeda at 2 sites in Japan.
Trial summary
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Azilsartan
- Type of treatment
- Pill or oral medicine
- How many people
- 3,437 participants
- Where
- 2 sitesJapan
- Study dates
- 20 Jun 2012to 15 Jan 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hypertension
Who may be able to join
- Hypertensive patients
Who cannot join
- Patients with a history of hypersensitivity to any of the ingredients of Azilsartan
- Patients who are pregnant or having possibilities of being pregnant
Trial locations and contacts
2 sites in 1 country.
About this study
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.
Read the detailed description
This surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in hypertensive patients in daily medical practice.
The usual dosage for adult is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patient's age and condition. The maximum daily dose is 40 mg.
- Conditions
- Hypertension
- Being tested
- Azilsartan
- Keywords
- Pharmacological therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzilsartanDrug
Also called Azilva Tablets
Azilsartan tablets
| Study group | Role | What they receive |
|---|---|---|
| Azilsartan | Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care. Receives: Drug: Azilsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Measured: Up to 12 Months
Secondary outcomes (2)
Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point
Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months).
Measured: Baseline, Month 1 and final assessment (up to 12 Months)
Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point
Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months).
Measured: Baseline, Month 1 and Final assessment (up to 12 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study start20 Jun 2012
- Primary completion15 Jan 2016
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Prospective
- Enrolment
- 3,437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092025
- Sponsor's protocol ID
- 279-011
- Other IDs
- JapicCTI-142441
- Status last verified
- Jul 2018
- First submitted
- 26 Feb 2014
- Last updated
- 15 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
- ClinicalTrials.gov ID
- NCT02092025
- Acronym / sponsor ID
- 279-011
- Conditions
- Hypertension
- Keywords
- Pharmacological therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,437 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2012 (actual)
- Primary completion
- 15 Jan 2016 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Posted 15 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.
Detailed description
This surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in hypertensive patients in daily medical practice.
The usual dosage for adult is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patient's age and condition. The maximum daily dose is 40 mg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azilsartan | – | Drug: AzilsartanAzilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hypertension
Key inclusion criteria (1 listed)
- Hypertensive patients
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity to any of the ingredients of Azilsartan
- Patients who are pregnant or having possibilities of being pregnant
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 |
|---|---|---|
| AzilsartanAlso: Azilva TabletsAzilsartan tablets | Drug | Azilsartan |
Primary outcome
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Time frame: Up to 12 Months
ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
2 secondary outcomes
Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point
Time frame: Baseline, Month 1 and final assessment (up to 12 Months)
Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point
Time frame: Baseline, Month 1 and Final assessment (up to 12 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Study Director study director
Takeda
2 sites 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 Takeda at 2 sites 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 15 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) (time frame: Up to 12 Months). 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 15 Jan 2019.