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Trial record 19 of 913 for:    tablet | Japan

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

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.
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

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

Condition or disease Intervention/treatment
Hypertension 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.


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Study Type : Observational
Actual Enrollment : 387 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Azilva Tablets Special Drug Use Surveillance "Hypertension Complicated by Diabetes "
Actual Study Start Date : March 3, 2014
Actual Primary Completion Date : February 29, 2016
Actual Study Completion Date : February 29, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   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 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

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
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Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02100319     History of Changes
Other Study ID Numbers: 279-012
JapicCTI-142466 ( Registry Identifier: JapicCTI )
First Posted: March 31, 2014    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: March 21, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Azilsartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action