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Trial record 1 of 1 for:    279-012
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Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02100319
First Posted: March 31, 2014
Last Update Posted: July 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
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

Condition Intervention
Hypertension Drug: Azilsartan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Azilva Tablets Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 373
Study Start Date: April 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Azilsartan at a dose of 20 to 40 mg, orally, once daily
Azilsartan tablets
Drug: Azilsartan
Azilsartan tablets
Other Name: Azilva Tablets

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.

Subject 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 patient's age and condition. The maximum daily dose is 40 mg.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypertension
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 subject enrollment and will continue such treatment until the first administration of Azilva Tablets)
    3. Patients who has a systolic blood pressure of ≥ 130 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, subject enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilva Tablets) and Step-2 (at the time of prescription of Azilva Tablets).

Exclusion Criteria:

  • Patients with contraindications to azilsartan
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100319


Locations
Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02100319     History of Changes
Other Study ID Numbers: 279-012
JapicCTI-142466 ( Registry Identifier: JapicCTI )
First Submitted: March 6, 2014
First Posted: March 31, 2014
Last Update Posted: July 25, 2016
Last Verified: July 2016

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases