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

Completed

• Conditions: Hypertension
• Interventions: Drug: Azilsartan

• Registration Number: NCT02100319
• Lead Sponsor: Takeda

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.

Study Timeline

• Study Start: 2014-03-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Primary Completion: 2016-02-29
• Study Completion: 2016-02-29
• Results First Submitted: 2018-05-17
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-12
• Last Update Submitted: 2018-12-12
• Results First Posted: 2019-03-21
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azilsartan at a dose of 20 to 40 mg, orally, once daily	Azilsartan	Azilsartan tablets

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
Percentage of Participants Who Had One or More Adverse Events	Up to Week 24
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.
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.