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Completed

NCT Number: NCT02100319

Azilsaltan Tablets (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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hypertension who meet all the following criteria will be enrolled:
  • Patients who has complications of diabetes mellitus
  • 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)
  • 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
  • Patients who is an outpatient
  • 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

Treatment and study plan

Azilsartan

Drug

Azilsartan tablets

Other names: Azilva Tablets

Primary outcomes

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

    Time frame: 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.

  2. Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)

    Time frame: 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 outcomes

  1. Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution

    Time frame: 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.

  2. Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution

    Time frame: 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.

  3. Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution

    Time frame: 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.

  4. Percentage of Participants Who Had One or More Adverse Events

    Time frame: Up to Week 24

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2014
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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