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Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

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ClinicalTrials.gov Identifier: NCT02092025
Recruitment Status : Completed
First Posted : March 19, 2014
Results First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hypertension
Intervention Drug: Azilsartan
Enrollment 3437
Recruitment Details Participants took part in the study at 738 investigative sites in Japan, from 20 June 2012 to 15 January 2016.
Pre-assignment Details 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
Hide 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
Reason Not Completed
Case Report Forms Uncollected             44
Protocol Deviation             24
Arm/Group Title Azilsartan
Hide 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 Number of Baseline Participants 3369
Hide Baseline Analysis Population Description
Safety Analysis set included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3369 participants
68.3  (13.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3369 participants
Female
1690
  50.2%
Male
1679
  49.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 3369 participants
3369
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 2396 participants
60.81  (13.716)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
BMI   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 2261 participants
24.27  (4.096)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2].
[2]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Healthcare Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3369 participants
Outpatient
3291
  97.7%
Inpatient
78
   2.3%
[1]
Measure Description: Participants were categorized as outpatient and inpatient.
Medical Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3369 participants
Had no Presence of Medical Complications
956
  28.4%
Had Presence of Medical Complications
2413
  71.6%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
Estimated Glomerular Filtration Rate (eGFR)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3369 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3369 participants
Current Drinker
828
  24.6%
Not Current Drinker
1823
  54.1%
Unknown
718
  21.3%
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3369 participants
Never Smoked
1572
  46.7%
Current Smoker
396
  11.8%
Ex-Smoker
539
  16.0%
Unknown
862
  25.6%
Clinical Systolic Blood Pressure (SBP)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 3359 participants
155.1  (20.43)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Clinical Diastolic Blood Pressure (DBP)   [1] 
Mean (Standard Deviation)
Unit of measure:  Participants
Number Analyzed 3359 participants
86.7  (14.25)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
SBP/DBP Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3369 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   [1] 
Mean (Standard Deviation)
Unit of measure:  Bpm
Number Analyzed 2983 participants
74.1  (10.99)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Taking Hypertension Drug in 2 Months Before Baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3369 participants
Had Not Taken
1080
  32.1%
Had Taken
2289
  67.9%
1.Primary Outcome
Title Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Azilsartan
Hide 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 Number of Participants Analyzed 3369
Measure Type: Count of Participants
Unit of Measure: Participants
94
   2.8%
2.Secondary Outcome
Title Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 3359
Mean (Standard Deviation)
Unit of Measure: mmHg
Change in SBP at Month 1 Number Analyzed 2895 participants
-15.4  (19.99)
Change in SBP at Final Assessment Number Analyzed 3240 participants
-19.8  (22.80)
3.Secondary Outcome
Title Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 3359
Mean (Standard Deviation)
Unit of Measure: mmHg
Change in DBP at Month 1 Number Analyzed 2895 participants
-7.7  (12.55)
Change in DBP at Final Assessment Number Analyzed 3240 participants
-10.3  (13.91)
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
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Azilsartan
Affected / at Risk (%)
Total   10/3369 (0.30%) 
Cardiac disorders   
Prinzmetal angina  1  1/3369 (0.03%) 
Sinus arrest  1  1/3369 (0.03%) 
Bradycardia  1  1/3369 (0.03%) 
Cardiac failure  1  1/3369 (0.03%) 
Gastrointestinal disorders   
Ileus  1  1/3369 (0.03%) 
General disorders   
Asthenia  1  1/3369 (0.03%) 
Drowning  1  1/3369 (0.03%) 
Hepatobiliary disorders   
Bile duct stone  1  1/3369 (0.03%) 
Injury, poisoning and procedural complications   
Fall  1  1/3369 (0.03%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/3369 (0.03%) 
Nervous system disorders   
Cerebral infarction  1  1/3369 (0.03%) 
Loss of consciousness  1  1/3369 (0.03%) 
Renal and urinary disorders   
Renal impairment  1  1/3369 (0.03%) 
Acute kidney injury  1  1/3369 (0.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.4%
Azilsartan
Affected / at Risk (%)
Total   15/3369 (0.45%) 
Nervous system disorders   
Dizziness  1  15/3369 (0.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02092025     History of Changes
Other Study ID Numbers: 279-011
JapicCTI-142441 ( Registry Identifier: JapicCTI )
First Submitted: February 26, 2014
First Posted: March 19, 2014
Results First Submitted: September 25, 2017
Results First Posted: January 15, 2019
Last Update Posted: January 15, 2019