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Trial record 22 of 913 for:    tablet | Japan

Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

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: NCT02092025
Recruitment Status : Completed
First Posted : March 19, 2014
Results First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.

Condition or disease Intervention/treatment
Hypertension Drug: Azilsartan

Detailed Description:

This surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in hypertensive patients in daily medical practice.

The usual dosage for adult 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.


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Study Type : Observational
Actual Enrollment : 3437 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
Actual Study Start Date : June 20, 2012
Actual Primary Completion Date : January 15, 2016
Actual Study Completion Date : January 15, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Azilsartan
Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
Drug: Azilsartan
Azilsartan tablets
Other Name: Azilva Tablets




Primary Outcome Measures :
  1. Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) [ Time Frame: Up to 12 Months ]
    ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.


Secondary Outcome Measures :
  1. Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point [ Time Frame: Baseline, Month 1 and final assessment (up to 12 Months) ]
    Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months).

  2. Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point [ Time Frame: Baseline, Month 1 and Final assessment (up to 12 Months) ]
    Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months).



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:   Non-Probability Sample
Study Population
Hypertension
Criteria

Inclusion Criteria:

  • Hypertensive patients

Exclusion Criteria:

  1. Patients with a history of hypersensitivity to any of the ingredients of Azilsartan
  2. Patients who are pregnant or having possibilities of being pregnant

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): NCT02092025


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: NCT02092025     History of Changes
Other Study ID Numbers: 279-011
JapicCTI-142441 ( Registry Identifier: JapicCTI )
First Posted: March 19, 2014    Key Record Dates
Results First Posted: January 15, 2019
Last Update Posted: January 15, 2019
Last Verified: July 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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Azilsartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action