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
Last Update Posted : September 29, 2016
|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 :||3393 participants|
|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|
|Azilsartan 20mg to 40mg, orally, once daily||
Other Name: Azilva Tablets
- 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 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)
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 Chair:||Postmarketing Group Manager||Takeda|