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

Hypertension Clinical Trial

Official title:

Azilva Tablets Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100319
• Other study ID #: 279-012
• Secondary ID: JapicCTI-142466
• Status: Completed
• Start date: March 3, 2014
• Est. completion date: February 29, 2016

Study information

• Verified date: December 2018
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: February 29, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Azilsartan
Azilsartan tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

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