Clinical trial NCT02100319: Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "
Official title: Azilva Tablets Special Drug Use Surveillance "Hypertension Complicated by Diabetes "
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 387
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypertension

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution
timeFrame: From baseline up to final assessment point (up to Week 24)
measure: Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)
timeFrame: From baseline up to final assessment point (up to Week 24)
Secondary outcomes:
measure: Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution
timeFrame: From baseline up to final assessment point (up to Week 24)
measure: Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution
timeFrame: From baseline up to final assessment point (up to Week 24)
measure: Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution
timeFrame: From baseline up to final assessment point (up to Week 24)
measure: Percentage of Participants Who Had One or More Adverse Events
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: