Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"
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|ClinicalTrials.gov Identifier: NCT02181816|
Recruitment Status : Completed
First Posted : July 4, 2014
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment|
This survey was designed to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets LD & HD (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.
For adults, one azilsartan/amlodipine combination tablet (20 mg/2.5 mg [for LD tablets] or 20 mg/5 mg [for HD tablets] of azilsartan/amlodipine) is administered orally once daily. Azilsartan/amlodipine combination tablets should not be used as the first-line drug for the treatment of hypertension.
|Study Type :||Observational|
|Actual Enrollment :||1090 participants|
|Official Title:||Azilsartan/Amlodipine (Zacras) Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"|
|Actual Study Start Date :||June 26, 2014|
|Actual Primary Completion Date :||January 31, 2017|
|Actual Study Completion Date :||January 31, 2017|
Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.
Azilsartan/Amlodipine combination tablets LD & HD
Other Name: Zacras Combination Tablets LD & HD
- Percentage of Participants Who Had One or More Adverse Events [ Time Frame: Up to Month 12 ]
- Systolic Office Blood Pressure [ Time Frame: Baseline, Month 1, and final assessment point (up to Month 12) ]Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
- Diastolic Office Blood Pressure [ Time Frame: Baseline, Month 1, and final assessment point (up to Month 12) ]Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
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): NCT02181816
|Study Director:||Study Director||Takeda|