Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"

An observational study of Hypertension, run by Takeda at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets Low Dose (LD) \& High Dose (HD) (Zacras Combination Tablets LD \& HD) in hypertensive patients in daily medical practice. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hypertension
What is being tested?: Azilsartan/Amlodipine
Type of treatment: Pill or oral medicine
How many people: 1,090 participants
Where: 2 sitesJapan
Study dates: 26 Jun 2014to 31 Jan 2017
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

-Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey:
Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
Patients who are pregnant or having possibilities of being pregnant
Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Study site
Osaka
Study site
Tokyo

Other trials in Japan

About this study

Official title: Azilsartan/Amlodipine (Zacras) Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"

Read the detailed description

This survey was designed to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets LD \& HD (Zacras Combination Tablets LD \& HD) in hypertensive patients in daily medical practice.

For adults, one azilsartan/amlodipine combination tablet (20 mg/2.5 mg [for LD tablets] or 20 mg/5 mg [for HD tablets] of azilsartan/amlodipine) is administered orally once daily. Azilsartan/amlodipine combination tablets should not be used as the first-line drug for the treatment of hypertension.

Conditions: Hypertension
Being tested: Azilsartan/Amlodipine
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.

Azilsartan/AmlodipineDrug
Also called Zacras Combination Tablets LD & HD
Azilsartan/Amlodipine combination tablets LD \& HD

Study groups in NCT02181816
Study group	Role	What they receive
Azilsartan/Amlodipine		Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care. Receives: Drug: Azilsartan/Amlodipine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Had One or More Adverse Events
Measured: Up to Month 12

Secondary outcomes (2)

Systolic Office Blood Pressure
Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
Measured: Baseline, Month 1, and final assessment point (up to Month 12)
Diastolic Office Blood Pressure
Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
Measured: Baseline, Month 1, and final assessment point (up to Month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 201431 Jan 2017

First posted4 Jul 2014 (estimated)
Study start26 Jun 2014
Primary completion31 Jan 2017
Study completion31 Jan 2017

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: 1,090 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02181816
Sponsor's protocol ID: 212-011
Other IDs: JapicCTI-142592
Status last verified: Feb 2019
First submitted: 2 Jul 2014
Last updated: 3 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Azilsartan/Amlodipine (Zacras) Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"
ClinicalTrials.gov ID: NCT02181816
Acronym / sponsor ID: 212-011
Conditions: Hypertension
Keywords: Pharmacological therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 1,090 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 26 Jun 2014 (actual)
Primary completion: 31 Jan 2017 (actual)
Study completion: 31 Jan 2017 (actual)
First posted: 4 Jul 2014 (estimated)
Results: Posted 3 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Azilsartan/Amlodipine	–	Drug: Azilsartan/AmlodipineAzilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. 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 (4 listed)

-Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey:
Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
Patients who are pregnant or having possibilities of being pregnant
Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)

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
Azilsartan/AmlodipineAlso: Zacras Combination Tablets LD & HDAzilsartan/Amlodipine combination tablets LD \& HD	Drug	Azilsartan/Amlodipine

Primary outcome

Percentage of Participants Who Had One or More Adverse Events
Time frame: Up to Month 12

2 secondary outcomes

Systolic Office Blood Pressure
Time frame: Baseline, Month 1, and final assessment point (up to Month 12)
Diastolic Office Blood Pressure
Time frame: Baseline, Month 1, and final assessment point (up to Month 12)

Results and safety

Results posted to the registry on 3 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azilsartan/Amlodipine	1,090	1,031

Primary outcome: Percentage of Participants Who Had One or More Adverse Events

Time frame: Up to Month 12. Number. Unit: Percentage of Participants

Measure	Azilsartan/Amlodipine n = 1031
Value	8.34

Population analysed: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Month 12. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azilsartan/Amlodipine	16 of 1,031 (1.6%)	15 of 1,031 (1.5%)	6 of 1,031

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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 4 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 3 Jun 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 3 Jun 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?

Percentage of Participants Who Had One or More Adverse Events (time frame: Up to Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02181816.

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 3 Jun 2019.