Trial Outcomes & Findings for Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes " (NCT NCT02100319)

NCT ID: NCT02100319

Last Updated: 2019-03-21

Results Overview

Reported data were changes from baseline in blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) measured at the medical institution.

• Recruitment status: COMPLETED
• Target enrollment: 387 participants
• Primary outcome timeframe: From baseline up to final assessment point (up to Week 24)
• Results posted on: 2019-03-21

Participant Flow

Participants took part in the study at 146 investigative sites in Japan, from 03 March 2014 to 29 February 2016.

Participants with a historical diagnosis of both hypertension and type 2 diabetes mellitus were enrolled. Participants received interventions as part of routine medical care.

Participant milestones

Measure	Azilsartan 20 to 40 mg 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 Study STARTED	387
Overall Study COMPLETED	371
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Azilsartan 20 to 40 mg 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 Study Case Report Forms Uncollected	11
Overall Study Protocol Deviation	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Azilsartan 20 to 40 mg n=371 Participants 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.
Age, Continuous	66.8 Years STANDARD_DEVIATION 11.74 • n=371 Participants
Sex: Female, Male Female	150 Participants n=371 Participants
Sex: Female, Male Male	221 Participants n=371 Participants
Region of Enrollment Japan	371 Participants n=371 Participants
Type of Diabetes Mellitus Type 1 Diabetes Mellitus	2 Participants n=371 Participants
Type of Diabetes Mellitus Type 2 Diabetes Mellitus	369 Participants n=371 Participants
Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity	345 Participants n=371 Participants
Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity	11 Participants n=371 Participants
Predisposition to Hypersensitivity Unknown	15 Participants n=371 Participants
Medical Complications Had No Presence of Medical Complications	77 Participants n=371 Participants
Medical Complications Had Presence of Medical Complications	294 Participants n=371 Participants
Estimated Glomerular Filtration Rate (eGFR) >= 15 mL/min/1.73m^2 and < 30 mL/min/1.73m^2	4 Participants n=277 Participants • The number analyzed is the number of participants with data available for analysis.
Estimated Glomerular Filtration Rate (eGFR) >= 30 mL/min/1.73m^2 and < 45 mL/min/1.73m^2	24 Participants n=277 Participants • The number analyzed is the number of participants with data available for analysis.
Estimated Glomerular Filtration Rate (eGFR) >= 45 mL/min/1.73m^2 and < 60 mL/min/1.73m^2	57 Participants n=277 Participants • The number analyzed is the number of participants with data available for analysis.
Estimated Glomerular Filtration Rate (eGFR) >= 60 mL/min/1.73m^2 and < 90 mL/min/1.73m^2	145 Participants n=277 Participants • The number analyzed is the number of participants with data available for analysis.
Estimated Glomerular Filtration Rate (eGFR) >= 90 mL/min/1.73m^2	47 Participants n=277 Participants • The number analyzed is the number of participants with data available for analysis.
BMI	25.91 kg/m^2 STANDARD_DEVIATION 4.667 • n=306 Participants • The number analyzed is the number of participants with data available for analysis.
Smoking Classification Never Smoked	173 Participants n=371 Participants
Smoking Classification Current Smoker	48 Participants n=371 Participants
Smoking Classification Ex-Smoker	94 Participants n=371 Participants
Smoking Classification Unknown	56 Participants n=371 Participants
Drinking Habits Yes	73 Participants n=371 Participants
Drinking Habits No	241 Participants n=371 Participants
Drinking Habits Unknown	57 Participants n=371 Participants
Pre-treatment ARB before Study Start Losartan	32 Participants n=371 Participants
Pre-treatment ARB before Study Start Candesartan	88 Participants n=371 Participants
Pre-treatment ARB before Study Start Valsartan	58 Participants n=371 Participants
Pre-treatment ARB before Study Start Telmisartan	89 Participants n=371 Participants
Pre-treatment ARB before Study Start Olmesartan	66 Participants n=371 Participants
Pre-treatment ARB before Study Start Irbesartan	38 Participants n=371 Participants

PRIMARY outcome

Timeframe: From baseline up to final assessment point (up to Week 24)

Population: 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.

Reported data were changes from baseline in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) measured at the medical institution.

Outcome measures

Measure	Azilsartan 20 to 40 mg n=371 Participants 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.
Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution Systolic Blood Pressure (SBP)	-10.5 Millimeter of Mercury (mmHg) Standard Deviation 18.40
Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution Diastolic Blood Pressure (DBP)	-5.1 Millimeter of Mercury (mmHg) Standard Deviation 11.57

PRIMARY outcome

Timeframe: From baseline up to final assessment point (up to Week 24)

Population: 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.

Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime.

Outcome measures

Measure	Azilsartan 20 to 40 mg n=371 Participants 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.
Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24) SBP Right after Waking-up	-7.9 mmHg Standard Deviation 14.86
Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24) DBP Right after Waking-up	-4.1 mmHg Standard Deviation 8.07
Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24) SBP at Bedtime	-7.1 mmHg Standard Deviation 13.82
Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24) DBP at Bedtime	-4.3 mmHg Standard Deviation 7.76

SECONDARY outcome

Timeframe: From baseline up to final assessment point (up to Week 24)

Population: 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.

Reported data were changes from baseline in pulse rate measured at the medical institution.

Outcome measures

Measure	Azilsartan 20 to 40 mg n=371 Participants 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.
Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution	-1.3 Beat per Minutes (bpm) Standard Deviation 10.22

SECONDARY outcome

Timeframe: From baseline up to final assessment point (up to Week 24)

Population: 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.

Reported data were changes from baseline in HbA1c (National glycohemoglobin standardization program [NGSP] value) measured at the Medical Institution.

Outcome measures

Measure	Azilsartan 20 to 40 mg n=371 Participants 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.
Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution	6.72 Percent Standard Deviation 0.792

SECONDARY outcome

Timeframe: From baseline up to final assessment point (up to Week 24)

Population: 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.

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.

Outcome measures

Measure	Azilsartan 20 to 40 mg n=371 Participants 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.
Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution	-44.344 mg/gCr Standard Deviation 413.9519

SECONDARY outcome

Timeframe: Up to Week 24

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

Outcome measures

Measure	Azilsartan 20 to 40 mg n=371 Participants 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.
Percentage of Participants Who Had One or More Adverse Events	6.47 Percentage of Participants

Adverse Events

Azilsartan 20 to 40 mg

Serious events: 5 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Measure	Azilsartan 20 to 40 mg n=371 participants at risk 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.
Infections and infestations Sepsis	0.27% 1/371 • Up to Week 24 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.
Metabolism and nutrition disorders Hypoglycaemia	0.27% 1/371 • Up to Week 24 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.
Cardiac disorders Cardiac failure	0.27% 1/371 • Up to Week 24 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.27% 1/371 • Up to Week 24 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.27% 1/371 • Up to Week 24 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.
Gastrointestinal disorders Diarrhoea	0.27% 1/371 • Up to Week 24 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.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.27% 1/371 • Up to Week 24 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.
General disorders Sudden death	0.27% 1/371 • Up to Week 24 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.

Other adverse events

Measure	Azilsartan 20 to 40 mg n=371 participants at risk 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.
Metabolism and nutrition disorders Diabetes mellitus	1.9% 7/371 • Up to Week 24 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.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.27% 1/371 • Up to Week 24 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.
Metabolism and nutrition disorders Hyperglycaemia	0.27% 1/371 • Up to Week 24 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.
Metabolism and nutrition disorders Hypoglycaemia	0.27% 1/371 • Up to Week 24 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.
Metabolism and nutrition disorders Dyslipidaemia	0.27% 1/371 • Up to Week 24 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.
Nervous system disorders Dizziness postural	0.27% 1/371 • Up to Week 24 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.
Nervous system disorders Sciatica	0.27% 1/371 • Up to Week 24 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.
Cardiac disorders Atrial fibrillation	0.27% 1/371 • Up to Week 24 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.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.27% 1/371 • Up to Week 24 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.
Gastrointestinal disorders Stomatitis	0.27% 1/371 • Up to Week 24 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.
Gastrointestinal disorders Large intestine polyp	0.27% 1/371 • Up to Week 24 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.
Reproductive system and breast disorders Vaginal discharge	0.27% 1/371 • Up to Week 24 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.
General disorders Feeling abnormal	0.27% 1/371 • Up to Week 24 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.
General disorders Oedema peripheral	0.27% 1/371 • Up to Week 24 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.
Investigations Blood pressure increased	0.54% 2/371 • Up to Week 24 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.
Investigations Blood glucose increased	0.27% 1/371 • Up to Week 24 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.
Investigations Glycosylated haemoglobin increased	0.81% 3/371 • Up to Week 24 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.
Investigations Blood creatinine increased	0.27% 1/371 • Up to Week 24 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.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER