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Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

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ClinicalTrials.gov Identifier: NCT02100319
Recruitment Status : Completed
First Posted : March 31, 2014
Results First Posted : March 21, 2019
Last Update Posted : March 21, 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 387
Recruitment Details Participants took part in the study at 146 investigative sites in Japan, from 03 March 2014 to 29 February 2016.
Pre-assignment Details Participants with a historical diagnosis of both hypertension and type 2 diabetes mellitus were enrolled. Participants received interventions as part of routine medical care.
Arm/Group Title Azilsartan 20 to 40 mg
Hide Arm/Group Description Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
Period Title: Overall Study
Started 387
Completed 371
Not Completed 16
Reason Not Completed
Case Report Forms Uncollected             11
Protocol Deviation             5
Arm/Group Title Azilsartan 20 to 40 mg
Hide Arm/Group Description Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
Overall Number of Baseline Participants 371
Hide Baseline Analysis Population Description
Safety Analysis Set: The safety analysis set was defined as all participants who completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 371 participants
66.8  (11.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants
Female
150
  40.4%
Male
221
  59.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 371 participants
371
Type of Diabetes Mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants
Type 1 Diabetes Mellitus
2
   0.5%
Type 2 Diabetes Mellitus
369
  99.5%
Predisposition to Hypersensitivity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants
Had No Predisposition to Hypersensitivity
345
  93.0%
Had Predisposition to Hypersensitivity
11
   3.0%
Unknown
15
   4.0%
[1]
Measure Description: The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.
Medical Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants
Had No Presence of Medical Complications
77
  20.8%
Had Presence of Medical Complications
294
  79.2%
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study excluding type 2 diabetes mellitus. 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)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants
>= 15 mL/min/1.73m^2 and < 30 mL/min/1.73m^2
4
   1.4%
>= 30 mL/min/1.73m^2 and < 45 mL/min/1.73m^2
24
   8.7%
>= 45 mL/min/1.73m^2 and < 60 mL/min/1.73m^2
57
  20.6%
>= 60 mL/min/1.73m^2 and < 90 mL/min/1.73m^2
145
  52.3%
>= 90 mL/min/1.73m^2
47
  17.0%
[1]
Measure Description: Here "mL" is milliliter, “min” is minute, and “m” is meter.
[2]
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 306 participants
25.91  (4.667)
[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.
Smoking Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants
Never Smoked
173
  46.6%
Current Smoker
48
  12.9%
Ex-Smoker
94
  25.3%
Unknown
56
  15.1%
Drinking Habits   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants
Yes
73
  19.7%
No
241
  65.0%
Unknown
57
  15.4%
[1]
Measure Description: Participants who answered Yes or No for a question “Drink Alcohol Almost Every Day?" were reported
Pre-treatment ARB before Study Start   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 371 participants
Losartan
32
   8.6%
Candesartan
88
  23.7%
Valsartan
58
  15.6%
Telmisartan
89
  24.0%
Olmesartan
66
  17.8%
Irbesartan
38
  10.2%
[1]
Measure Description: ARB = Angiotensin II Receptor Blocker. Reported data was treatment drug of ARB before observational duration.
1.Primary Outcome
Title Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution
Hide Description Reported data were changes from baseline in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) measured at the medical institution.
Time Frame From baseline up to final assessment point (up to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description

Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.

The analyzed numbers were participants who were evaluable for this outcome measure.

Arm/Group Title Azilsartan 20 to 40 mg
Hide Arm/Group Description:
Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 371
Mean (Standard Deviation)
Unit of Measure: Millimeter of Mercury (mmHg)
Systolic Blood Pressure (SBP) Number Analyzed 355 participants
-10.5  (18.40)
Diastolic Blood Pressure (DBP) Number Analyzed 355 participants
-5.1  (11.57)
2.Primary Outcome
Title Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)
Hide Description Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime.
Time Frame From baseline up to final assessment point (up to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description

Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.

The analyzed numbers were participants who were evaluable for this outcome measure.

Arm/Group Title Azilsartan 20 to 40 mg
Hide Arm/Group Description:
Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 371
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP Right after Waking-up Number Analyzed 246 participants
-7.9  (14.86)
DBP Right after Waking-up Number Analyzed 246 participants
-4.1  (8.07)
SBP at Bedtime Number Analyzed 138 participants
-7.1  (13.82)
DBP at Bedtime Number Analyzed 138 participants
-4.3  (7.76)
3.Secondary Outcome
Title Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution
Hide Description Reported data were changes from baseline in pulse rate measured at the medical institution.
Time Frame From baseline up to final assessment point (up to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description

Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.

The analyzed numbers were participants who were evaluable for this outcome measure.

Arm/Group Title Azilsartan 20 to 40 mg
Hide Arm/Group Description:
Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 371
Mean (Standard Deviation)
Unit of Measure: Beat per Minutes (bpm)
-1.3  (10.22)
4.Secondary Outcome
Title Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution
Hide Description Reported data were changes from baseline in HbA1c (National glycohemoglobin standardization program [NGSP] value) measured at the Medical Institution.
Time Frame From baseline up to final assessment point (up to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description

Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.

The analyzed numbers were participants who were evaluable for this outcome measure.

Arm/Group Title Azilsartan 20 to 40 mg
Hide Arm/Group Description:
Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 371
Mean (Standard Deviation)
Unit of Measure: Percent
6.72  (0.792)
5.Secondary Outcome
Title Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution
Hide Description Reported data were changes from baseline in creatinine-adjusted urinary albumin level (that is calculated from urinary albumin level divided by creatinine level) measured at the medical institution. Here “mg/gCr” is Milligrams per Gram of Creatinine.
Time Frame From baseline up to final assessment point (up to Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description

Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.

The analyzed numbers were participants who were evaluable for this outcome measure.

Arm/Group Title Azilsartan 20 to 40 mg
Hide Arm/Group Description:
Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 371
Mean (Standard Deviation)
Unit of Measure: mg/gCr
-44.344  (413.9519)
6.Secondary Outcome
Title Percentage of Participants Who Had One or More Adverse Events
Hide Description [Not Specified]
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Arm/Group Title Azilsartan 20 to 40 mg
Hide Arm/Group Description:
Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
Overall Number of Participants Analyzed 371
Measure Type: Number
Unit of Measure: Percentage of Participants
6.47
Time Frame Up to Week 24
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events 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.
 
Arm/Group Title Azilsartan 20 to 40 mg
Hide Arm/Group Description Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 24 weeks in participants based upon the disease severity. Participants received interventions as part of routine medical care.
All-Cause Mortality
Azilsartan 20 to 40 mg
Affected / at Risk (%)
Total   2/371 (0.54%) 
Show Serious Adverse Events Hide Serious Adverse Events
Azilsartan 20 to 40 mg
Affected / at Risk (%)
Total   5/371 (1.35%) 
Cardiac disorders   
Cardiac failure  1  1/371 (0.27%) 
Gastrointestinal disorders   
Diarrhoea  1  1/371 (0.27%) 
General disorders   
Sudden death  1 [1]  1/371 (0.27%) 
Infections and infestations   
Sepsis  1  1/371 (0.27%) 
Metabolism and nutrition disorders   
Hypoglycaemia  1  1/371 (0.27%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/371 (0.27%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/371 (0.27%) 
Dyspnoea  1  1/371 (0.27%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
[1]
The reasons of events are not determined because assessment findings were insufficient to specify the reason.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azilsartan 20 to 40 mg
Affected / at Risk (%)
Total   20/371 (5.39%) 
Cardiac disorders   
Atrial fibrillation  1  1/371 (0.27%) 
Gastrointestinal disorders   
Gastrooesophageal reflux disease  1  1/371 (0.27%) 
Stomatitis  1  1/371 (0.27%) 
Large intestine polyp  1  1/371 (0.27%) 
General disorders   
Feeling abnormal  1  1/371 (0.27%) 
Oedema peripheral  1  1/371 (0.27%) 
Investigations   
Blood pressure increased  1  2/371 (0.54%) 
Blood glucose increased  1  1/371 (0.27%) 
Glycosylated haemoglobin increased  1  3/371 (0.81%) 
Blood creatinine increased  1  1/371 (0.27%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1  7/371 (1.89%) 
Diabetes mellitus inadequate control  1  1/371 (0.27%) 
Hyperglycaemia  1  1/371 (0.27%) 
Hypoglycaemia  1  1/371 (0.27%) 
Dyslipidaemia  1  1/371 (0.27%) 
Nervous system disorders   
Dizziness postural  1  1/371 (0.27%) 
Sciatica  1  1/371 (0.27%) 
Reproductive system and breast disorders   
Vaginal discharge  1  1/371 (0.27%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
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: NCT02100319     History of Changes
Other Study ID Numbers: 279-012
JapicCTI-142466 ( Registry Identifier: JapicCTI )
First Submitted: March 6, 2014
First Posted: March 31, 2014
Results First Submitted: May 17, 2018
Results First Posted: March 21, 2019
Last Update Posted: March 21, 2019