Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02092025
• Collaborator: (none)
• Enrollment: 3,437
• Locations: 2
• Actual Duration (Months): 42.8
• Patients Per Site: 1718.5
• Patients Per Site Per Month: 40.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Azilsartan

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

• Study Type: Observational
• Actual Enrollment: 3437 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
• Actual Study Start Date: Jun 20, 2012
• Actual Primary Completion Date: Jan 15, 2016
• Actual Study Completion Date: Jan 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Azilsartan; Azilsartan tablets; Other Names: Azilva Tablets

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) [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.

Secondary Outcome Measures

1. Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point [Baseline, Month 1 and final assessment (up to 12 Months)]

   Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months).

2. Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point [Baseline, Month 1 and Final assessment (up to 12 Months)]

   Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hypertensive patients

Exclusion Criteria:

1. Patients with a history of hypersensitivity to any of the ingredients of Azilsartan

2. Patients who are pregnant or having possibilities of being pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Osaka		Japan
2		Tokyo		Japan

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02092025
• Other Study ID Numbers: 279-011; JapicCTI-142441
• First Posted: Mar 19, 2014
• Last Update Posted: Jan 15, 2019
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Takeda: Pharmacological therapy
• Additional relevant MeSH terms: Hypertension; Azilsartan medoxomil

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 738 investigative sites in Japan, from 20 June 2012 to 15 January 2016.
Pre-assignment Detail	Participants with a historical diagnosis of hypertension were enrolled to receive Azilsartan 20 milligram (mg) - 40 mg tablet, orally, once daily for up to 12 months.

Arm/Group Title	Azilsartan
Arm/Group Description	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.
Period Title: Overall Study
STARTED	3437
COMPLETED	3369
NOT COMPLETED	68

Baseline Characteristics

Arm/Group Title	Azilsartan
Arm/Group Description	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.
Overall Participants	3369
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.3 (13.48)
Sex: Female, Male (Count of Participants)
Female	1690 50.2%
Male	1679 49.8%
Region of Enrollment (Number) [Number]
Japan	3369 100%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	60.81 (13.716)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	24.27 (4.096)
Healthcare Category (Count of Participants)
Outpatient	3291 97.7%
Inpatient	78 2.3%
Medical Complications (Count of Participants)
Had no Presence of Medical Complications	956 28.4%
Had Presence of Medical Complications	2413 71.6%
Estimated Glomerular Filtration Rate (eGFR) (Count of Participants)
< 15 mL/min/1.73 m^2	61 1.8%
≥ 15 mL/min/1.73 m^2 and < 30 mL/min/1.73 m^2	45 1.3%
≥ 30 mL/min/1.73 m^2 and < 45 mL/min/1.73 m^2	184 5.5%
≥ 45 mL/min/1.73 m^2 and < 60 mL/min/1.73 m^2	390 11.6%
≥ 60 mL/min/1.73 m^2 and < 90 mL/min/1.73 m^2	1198 35.6%
≥ 90 mL/min/1.73 m^2	288 8.5%
Unknown	1203 35.7%
Drinking Habits (Count of Participants)
Current Drinker	828 (20.43) 24.6%
Not Current Drinker	1823 54.1%
Unknown	718 21.3%
Smoking Classification (Count of Participants)
Never Smoked	1572 (14.25) 46.7%
Current Smoker	396 11.8%
Ex-Smoker	539 16%
Unknown	862 25.6%
Clinical Systolic Blood Pressure (SBP) (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	155.1 (20.43)
Clinical Diastolic Blood Pressure (DBP) (Mean) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Participants]	86.7 (14.25) 2.6%
SBP/DBP Classification (Count of Participants)
SBP < 140 mmHg and DBP < 90 mmHg	552 16.4%
SBP ≥ 140 mmHg and DBP ≥ 90 mmHg	2807 83.3%
Not Measured	10 0.3%
Pulse Rate (bpm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [bpm]	74.1 (10.99)
Taking Hypertension Drug in 2 Months Before Baseline (Count of Participants)
Had Not Taken	1080 32.1%
Had Taken	2289 67.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Description	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.
Time Frame	Up to 12 Months

Outcome Measure Data

Analysis Population Description

Safety Analysis set included all participants who received at least 1 dose of study drug.

Arm/Group Title	Azilsartan
Arm/Group Description	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.
Measure Participants	3369
Count of Participants [Participants]	94 2.8%

2. Secondary Outcome

Title	Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point
Description	Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months).
Time Frame	Baseline, Month 1 and final assessment (up to 12 Months)

Outcome Measure Data

Analysis Population Description

The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given time point.

Arm/Group Title	Azilsartan
Arm/Group Description	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.
Measure Participants	3359
Change in SBP at Month 1	-15.4 (19.99)
Change in SBP at Final Assessment	-19.8 (22.80)

3. Secondary Outcome

Title	Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point
Description	Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months).
Time Frame	Baseline, Month 1 and Final assessment (up to 12 Months)

Outcome Measure Data

Analysis Population Description

The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given time point.

Arm/Group Title	Azilsartan
Arm/Group Description	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.
Measure Participants	3359
Change in DBP at Month 1	-7.7 (12.55)
Change in DBP at Final Assessment	-10.3 (13.91)

Adverse Events

Time Frame	Up to 12 Month
Adverse Event Reporting Description	Investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only non-serious ADRs were collected in this study. Participants may be represented in more than 1 category.
Arm/Group Title	Azilsartan
Arm/Group Description	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.
All Cause Mortality
	Azilsartan
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Azilsartan
	Affected / at Risk (%)	# Events
Total	10/3369 (0.3%)
Cardiac disorders
Prinzmetal angina	1/3369 (0%)
Sinus arrest	1/3369 (0%)
Bradycardia	1/3369 (0%)
Cardiac failure	1/3369 (0%)
Gastrointestinal disorders
Ileus	1/3369 (0%)
General disorders
Asthenia	1/3369 (0%)
Drowning	1/3369 (0%)
Hepatobiliary disorders
Bile duct stone	1/3369 (0%)
Injury, poisoning and procedural complications
Fall	1/3369 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/3369 (0%)
Nervous system disorders
Cerebral infarction	1/3369 (0%)
Loss of consciousness	1/3369 (0%)
Renal and urinary disorders
Renal impairment	1/3369 (0%)
Acute kidney injury	1/3369 (0%)
Other (Not Including Serious) Adverse Events
	Azilsartan
	Affected / at Risk (%)	# Events
Total	15/3369 (0.4%)
Nervous system disorders
Dizziness	15/3369 (0.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.