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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
Results First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date February 26, 2014
First Posted Date March 19, 2014
Results First Submitted Date September 25, 2017
Results First Posted Date January 15, 2019
Last Update Posted Date January 15, 2019
Actual Study Start Date June 20, 2012
Actual Primary Completion Date January 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2018)
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.
Original Primary Outcome Measures
 (submitted: March 17, 2014)
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.
Change History Complete list of historical versions of study NCT02092025 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 20, 2018)
  • 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).
  • 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).
Original Secondary Outcome Measures
 (submitted: March 17, 2014)
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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
Official Title Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hypertension
Condition Hypertension
Intervention Drug: Azilsartan
Azilsartan tablets
Other Name: Azilva Tablets
Study Groups/Cohorts 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.
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: July 20, 2018)
3437
Original Estimated Enrollment
 (submitted: March 17, 2014)
3000
Actual Study Completion Date January 15, 2016
Actual Primary Completion Date January 15, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
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 NCT02092025
Other Study ID Numbers 279-011
JapicCTI-142441 ( 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 July 2018