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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Azilsartan

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 Type: Observational
• Enrollment (Actual): 387

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hypertension

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Azilsartan at a dose of 20 to 40 mg, orally, once daily; Azilsartan tablets	Drug: Azilsartan; Azilsartan tablets; Other Names: Azilva Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Had One or More Adverse Events		Up to Week 24
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)
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)
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)

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2014
• Primary Completion (ACTUAL): February 29, 2016
• Study Completion (ACTUAL): February 29, 2016

Study Registration Dates

• First Submitted: March 6, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (ESTIMATE): March 31, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacological therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Azilsartan medoxomil
• Other Study ID Numbers: 279-012; JapicCTI-142466 (REGISTRY: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No