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

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ClinicalTrials.gov Identifier: NCT02100319
Recruitment Status : Completed
First Posted : March 31, 2014
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date March 6, 2014
First Posted Date March 31, 2014
Results First Submitted Date May 17, 2018
Results First Posted Date March 21, 2019
Last Update Posted Date March 21, 2019
Actual Study Start Date March 3, 2014
Actual Primary Completion Date February 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: March 26, 2014)
Changes from baseline in blood pressure measured at the medical institution and at home [ Time Frame: From baseline to 24 weeks ]
Summary statistics of measured values and respective changes from baseline will be calculated at each time point in daily medical practice
Change History Complete list of historical versions of study NCT02100319 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 12, 2018)
  • 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.
  • 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.
  • 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.
  • Percentage of Participants Who Had One or More Adverse Events [ Time Frame: Up to Week 24 ]
Original Secondary Outcome Measures
 (submitted: March 26, 2014)
  • Changes from baseline in pulse rate measured at the medical institution, HbA1c (National Glycohemoglobin Standardization Program [NGSP] value), and urinary albumin level (creatinine-adjusted value) [ Time Frame: From baseline to 24 weeks ]
    Summary statistics of measured values and respective changes from baseline will be calculated at each test time point in daily medical practice.
  • Changes from baseline in HbA1c (National Glycohemoglobin Standardization Program [NGSP] value) at the medical institution [ Time Frame: From baseline to 24 weeks ]
    Summary statistics of measured values and respective changes from baseline will be calculated at each test time point in daily medical practice.
  • Changes from baseline in urinary albumin level (creatinine-adjusted value) at the medical institution [ Time Frame: From baseline to 24 weeks ]
    Summary statistics of measured values and respective changes from baseline will be calculated at each test time point in daily medical practice
  • Frequency of adverse events [ Time Frame: For 24 weeks ]
    The frequency of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of azilsartan, whether or not it was considered related to the treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "
Official Title Azilva Tablets Special Drug Use Surveillance "Hypertension Complicated by Diabetes "
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Hypertension
Condition Hypertension
Intervention Drug: Azilsartan
Azilsartan tablets
Other Name: Azilva Tablets
Study Groups/Cohorts Azilsartan at a dose of 20 to 40 mg, orally, once daily
Azilsartan tablets
Intervention: Drug: Azilsartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 12, 2018)
387
Original Estimated Enrollment
 (submitted: March 26, 2014)
600
Actual Study Completion Date February 29, 2016
Actual Primary Completion Date February 29, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02100319
Other Study ID Numbers 279-012
JapicCTI-142466 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date December 2018