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Trial record 21 of 854 for:    tablet | Japan

Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

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ClinicalTrials.gov Identifier: NCT02092025
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study 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.


Study Type : Observational
Actual Enrollment : 3393 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
Study Start Date : June 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Frequency of adverse drug reactions [ Time Frame: For 12 months ]
    The frequencies of all adverse drug reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with administration of azilsartan whether or not it was considered related to the treatment. Among these, events which are considered to have a causal relationship with azilsartan are defined as adverse drug reactions.


Secondary Outcome Measures :
  1. Change from baseline in blood pressure [ Time Frame: Baseline and Month 12 ]
    Tabulation of actual measured value and changes from baseline at each test time point in blood pressure in daily medical practice (test value at each test time point after baseline - test value at baseline)



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

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
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by Takeda:
Pharmacological therapy