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
|Condition or disease||Intervention/treatment|
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 :||3437 participants|
|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|
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.
Other Name: Azilva Tablets
- 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.
- 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).
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
|Study Director:||Study Director||Takeda|