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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1252-3589 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the safety by determining the incidence rates of all adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected on the precaution in the use, ADRs already known, non-serious ADRs and other safety related information (laboratory values changes, etc).
This is a long-term prospective, observational post-marketing surveillance study of azilsartan medoxomil in participants with essential hypertension. This study will assess the safety and effectiveness of azilsartan medoxomil prescribed as a monotherapy or taken concomitantly with other anti-hypertension therapies in real-world clinical practice settings.
The study will enroll approximately 3000 participants. The data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
The multi-center study will be conducted in South Korea. Data collection will be based on routinely scheduled and emergency visits over the surveillance period, scheduled at Visit 1 (Baseline), Visit 2 (6 Weeks), Visit 3 (3 Months or more less than 6 Months) and Visit 4 (6 Months or more [Month 9]). The overall duration of the study will be approximately 6 years. All participants will be followed up for 9 months after drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Essential Hypertension | Participants diagnosed with essential hypertension and whom have been prescribed azilsartan medoxomil as a monotherapy or taken concomitantly with other anti-hypertension therapies in a routine clinical practical setting, will be observed prospectively over a period of 6 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan Medoxomil | Drug | Azilsartan Medoxomil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Experience at Least one AE and SAE | Baseline up to Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Blood Pressure Including Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Blood pressure (SBP and DBP) will be measured in millimeter of mercury (mmHg). | Baseline up to Month 9 |
| Percentage of Participants who Achieve Clinic DBP Less Than (<) 90 mmHg and/or Reduction of Greater Than or Equal to (>=) 10 mmHg |
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Inclusion Criteria:
With Essential Hypertension.
Newly prescribed and initiates azilsartan medoxomil for the treatment of hypertension, as a monotherapy or taken concomitantly with other anti-hypertension therapies.
Exclusion Criteria:
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Participants diagnosed with essential hypertension and whom have been prescribed azilsartan medoxomil as a monotherapy or taken concomitantly with other anti-hypertension therapies in a routine clinical practical setting.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Celltrion Pharm, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myongji Hospital | Goyang-si | Gyeonggi-do | 10475 | South Korea |
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C557413 | azilsartan medoxomil |
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| Baseline up to Month 9 |
| Percentage of Participants who Achieve Clinic SBP <140 mmHg and/or reduction of >=20 mmHg | Baseline up to Month 9 |
| Percentage of Participants who Achieve Both Clinic DBP <90 mmHg and/or Reduction of >=10 mmHg and Clinic SBP <140 mmHg and/or Reduction of >=20 mmHg | Baseline up to Month 9 |
| Change From Baseline in Serum Creatinine Level, Serum Uric Acid Level and Serum Lipid Profile | Serum creatinine level, serum uric acid level, and serum lipid profile will be measured in milligram per deciliter (mg/dL). | Baseline up to Month 9 |
| Change From Baseline in Blood Potassium Level | Blood potassium level will be measured in millimole per liter (mmol/L). | Baseline up to Month 9 |
| Change From Baseline in Blood Sodium Profiles | Blood sodium profiles will be measured in milliequivalent per liter (mEq/L). | Baseline up to Month 9 |
| Final Effectiveness Rate as Assessed by the Investigator | Effectiveness rate: percentage of participants who achieved effectiveness over total number of assessable effectiveness analysis population, and is calculated as number of effective participants/total number of participants in group, multiplied by 100. Final effectiveness will be assessed based on: Improved (symptoms have improved or it is considered to have had a maintenance effect); Unchanged (no significant change from pre-administration, not considered to have had a maintenance effect); Worsened (symptoms have worsened compared to pre-administration); Unassessable (unable to assess due to grounds such as missing effectiveness variables, follow up loss, etc.). Maintenance effect: cases where the likelihood of worsened symptoms is high with discontinuation of medication, or equivalent effect to existing drugs is sustained when substituted with existing drugs. Effectiveness rate is determined by classifying 'Improved' as "Effective" and 'Unchanged' and 'Worsened' as "Ineffective". | Baseline up to Month 9 |