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CompletedNCT02181816Updated Jun 3, 2019Results posted

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

An observational study in Hypertension, sponsored by Takeda. Completed at 2 sites in Japan. Per ClinicalTrials.gov, last updated 2019-06-03.

Sponsored by Takeda · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,090
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Pharmacological therapy
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 1,090 is above the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Hypertension

Inclusion criteria

-Hypertensive patients

Exclusion criteria

Exclusion Criteria:

-Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey:

  1. Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
  2. Patients who are pregnant or having possibilities of being pregnant
  3. Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,090 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Drug: Azilsartan/Amlodipine

Interventions

  • DrugAzilsartan/Amlodipine

    Azilsartan/Amlodipine combination tablets LD \& HD

    Also known as: Zacras Combination Tablets LD & HD

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Who Had One or More Adverse Events

    Time frame: Up to Month 12

Secondary outcomes

  1. Systolic Office Blood Pressure

    Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.

    Time frame: Baseline, Month 1, and final assessment point (up to Month 12)

  2. Diastolic Office Blood Pressure

    Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.

    Time frame: Baseline, Month 1, and final assessment point (up to Month 12)

07

Results

Posted Jun 3, 2019

Participant flow

Participants took part in the study at 271 investigative sites in Japan, from 26 June 2014 to 31 January 2017.

Participant flow — Overall Study
MilestoneAzilsartan/Amlodipine
Started1090
Completed1031
Not completed59
Withdrew: Case report forms uncollected38
Withdrew: Protocol deviation21

Outcome measures

PrimaryPercentage of Participants Who Had One or More Adverse Events
Time frame:
Up to Month 12
Reported as:
Number · Percentage of Participants
Percentage of Participants Who Had One or More Adverse Events
Percentage of ParticipantsAzilsartan/Amlodipine
Percentage of Participants Who Had One or More Adverse Events8.34
SecondarySystolic Office Blood Pressure

Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.

Time frame:
Baseline, Month 1, and final assessment point (up to Month 12)
Reported as:
Mean · Millimeter of Mercury (mmHg)
Systolic Office Blood Pressure
Millimeter of Mercury (mmHg)Azilsartan/Amlodipine
Baseline149.5 ± 19.13
Month 1137.2 ± 14.69
Final Assessment Point133.0 ± 14.14
SecondaryDiastolic Office Blood Pressure

Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.

Time frame:
Baseline, Month 1, and final assessment point (up to Month 12)
Reported as:
Mean · mmHg
Diastolic Office Blood Pressure
mmHgAzilsartan/Amlodipine
Baseline83.3 ± 13.64
Month 177.4 ± 11.35
Final Assessment Point75.0 ± 10.88

Adverse events

Collected over Up to Month 12. Non-serious events are listed at a 0.5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Azilsartan/Amlodipine6/1,031 (0.6%)16/1,031 (1.6%)15/1,031 (1.5%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventAzilsartan/Amlodipine
Bile duct cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/1031
CholecystitisHepatobiliary disorders2/1031
PeritonitisInfections and infestations1/1031
PneumoniaInfections and infestations1/1031
Plasma cell myelomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1031
Renal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1031
Brain stem haemorrhageNervous system disorders1/1031
Cerebral infarctionNervous system disorders1/1031
Cardiac failureCardiac disorders1/1031
Prinzmetal anginaCardiac disorders1/1031
Most frequent other events
Most frequent other events
EventAzilsartan/Amlodipine
DizzinessNervous system disorders9/1031
Blood creatinine increasedInvestigations6/1031

Baseline characteristics

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

Age, Continuous
Age, Continuous(Years)Azilsartan/Amlodipine
Mean68.5 ± 12.92
Sex: Female, Male
Sex: Female, Male(Participants)Azilsartan/Amlodipine
Female482
Male549
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Azilsartan/Amlodipine
Region of Enrollment
Region of Enrollment(Participants)Azilsartan/Amlodipine
Japan1031
Duration of Diagnosis of Hypertension
Duration of Diagnosis of Hypertension(Participants)Azilsartan/Amlodipine
< 1 Year167
>= 1 Year and < 3 Years126
>= 3 Years and < 5 Years63
>= 5 Years312
Unknown363
Healthcare Category
Healthcare Category(Participants)Azilsartan/Amlodipine
Outpatient1027
Inpatient4
Predisposition to Hypersensitivity
Predisposition to Hypersensitivity(Participants)Azilsartan/Amlodipine
Had No Predisposition to Hypersensitivity909
Had Predisposition to Hypersensitivity58
Unknown64
Medical Complications
Medical Complications(Participants)Azilsartan/Amlodipine
Had No Medical Complications245
Had Medical Complications786

7 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Osaka, Japan
  • Tokyo, Japan
09

References and documents

Study documents

  • Study protocol · Jun 2, 2017
  • Statistical analysis plan · Nov 29, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02181816
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Jul 4, 2014
Start date
Jun 26, 2014
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017
Results posted
Jun 3, 2019
Last update
Jun 3, 2019

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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