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

Azilva Tablets Special Drug Use Surveillance Hypertension Complicated by Diabetes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02100319

Enrollment

387

Registered

2014-03-31

Start date

2014-03-03

Completion date

2016-02-29

Last updated

2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Pharmacological therapy

Brief summary

The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than azilsartan, in routine clinical practice

Detailed description

This study was designed to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with ARBs, other than azilsartan, in daily medical practice. Patient enrollment will be started on April 1, 2014. The usual dosage for adults is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the participant's age and condition. The maximum daily dose is 40 mg.

Interventions

DRUGAzilsartan

Azilsartan tablets

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with hypertension who meet all the following criteria will be enrolled: 1. Patients who has complications of diabetes mellitus 2. Patients who is on monotherapy with ARBs (other than azilsartan) as antihypertensive treatment (Patients who have continued monotherapy with the same ARB product for at least 8 weeks at the time of Step-1\* of participant enrollment and will continue such treatment until the first administration of Azilsartan Tablets) 3. Patients who has a systolic blood pressure of ≥ 130 millimeter of mercury (mmHg) and/or diastolic blood pressure of 80 ≥ mmHg at the examination performed at the medical institution 4. Patients who is an outpatient 5. Patient who keeps a regular lifestyle and whose usual waking time is between 4 a.m. and 9:30 a.m. \*For this surveillance, participant enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilsartan Tablets) and Step-2 (at the time of prescription of Azilsartan Tablets).

Exclusion criteria

* Patients with contraindications to azilsartan

Design outcomes

Primary

Measure	Time frame	Description
Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution	From baseline up to final assessment point (up to Week 24)	Reported data were changes from baseline in blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) measured at the medical institution.
Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)	From baseline up to final assessment point (up to Week 24)	Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime.

Secondary

Measure	Time frame	Description
Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution	From baseline up to final assessment point (up to Week 24)	Reported data were changes from baseline in pulse rate measured at the medical institution.
Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution	From baseline up to final assessment point (up to Week 24)	Reported data were changes from baseline in HbA1c (National glycohemoglobin standardization program \[NGSP\] value) measured at the Medical Institution.
Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution	From baseline up to final assessment point (up to Week 24)	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.
Percentage of Participants Who Had One or More Adverse Events	Up to Week 24	—

Countries

Japan

Participant flow

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.

Participants by arm

Arm	Count
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.	371
Total	371

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Case Report Forms Uncollected	11
Overall Study	Protocol Deviation	5

Baseline characteristics

Characteristic	Azilsartan 20 to 40 mg	—
Age, Continuous	66.8 Years STANDARD_DEVIATION 11.74	—
BMI	25.91 kg/m^2 STANDARD_DEVIATION 4.667	—
Drinking Habits No	241 Participants	—
Drinking Habits Unknown	57 Participants	—
Drinking Habits Yes	73 Participants	—
Estimated Glomerular Filtration Rate (eGFR) >= 15 mL/min/1.73m^2 and < 30 mL/min/1.73m^2	4 Participants	—
Estimated Glomerular Filtration Rate (eGFR) >= 30 mL/min/1.73m^2 and < 45 mL/min/1.73m^2	24 Participants	—
Estimated Glomerular Filtration Rate (eGFR) >= 45 mL/min/1.73m^2 and < 60 mL/min/1.73m^2	57 Participants	—
Estimated Glomerular Filtration Rate (eGFR) >= 60 mL/min/1.73m^2 and < 90 mL/min/1.73m^2	145 Participants	—
Estimated Glomerular Filtration Rate (eGFR) >= 90 mL/min/1.73m^2	47 Participants	—
Medical Complications Had No Presence of Medical Complications	77 Participants	—
Medical Complications Had Presence of Medical Complications	294 Participants	—
Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity	345 Participants	—
Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity	11 Participants	—
Predisposition to Hypersensitivity Unknown	15 Participants	—
Pre-treatment ARB before Study Start Candesartan	88 Participants	—
Pre-treatment ARB before Study Start Irbesartan	38 Participants	—
Pre-treatment ARB before Study Start Losartan	32 Participants	—
Pre-treatment ARB before Study Start Olmesartan	66 Participants	—
Pre-treatment ARB before Study Start Telmisartan	89 Participants	—
Pre-treatment ARB before Study Start Valsartan	58 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Japan	371 Participants	—
Sex: Female, Male Female	150 Participants	—
Sex: Female, Male Male	221 Participants	—
Smoking Classification Current Smoker	48 Participants	—
Smoking Classification Ex-Smoker	94 Participants	—
Smoking Classification Never Smoked	173 Participants	—
Smoking Classification Unknown	56 Participants	—
Type of Diabetes Mellitus Type 1 Diabetes Mellitus	2 Participants	—
Type of Diabetes Mellitus Type 2 Diabetes Mellitus	369 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	2 / 371
other Total, other adverse events	20 / 371
serious Total, serious adverse events	5 / 371

Outcome results

Primary

Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution

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