- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04470817
A Study for PMS of AZL-M in the Treatment of Adult Participants With Essential Hypertension in South Korea
Post-Marketing Surveillance (Usage Results Study) of Azilsartan Medoxomil in the Treatment of Adult Patients With Essential Hypertension in South Korea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Participants With Essential Hypertension
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Takeda Study Registration Call Center
- Phone Number: 1-877-825-3327
- Email: medinfoUS@takeda.com
Study Locations
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republic of, 10475
- Myongji Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
With Essential Hypertension.
- Newly diagnosed with essential hypertension or who have no long-term history of hypertension medication after diagnosis (The participant has a SBP or DBP >=140 or 90 mmHG, respectively).
- Receiving treatment with other hypertension medications.
- Newly prescribed and initiates azilsartan medoxomil for the treatment of hypertension, as a monotherapy or taken concomitantly with other anti-hypertension therapies.
Exclusion Criteria:
- Treated with azilsartan medoxomil outside of the locally approved label in South Korea.
- With known hypersensitivity or presence of any contraindication to azilsartan medoxomil.
- Use of aliskiren in combination with azilsartan medoxomil in participants with diabetes or with moderate to severe renal impairment (glomerular filtration rate [GFR ] < 60 milliliter per minute [mL/min]/1.73 m^2).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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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Azilsartan Medoxomil
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants who Experience at Least one AE and SAE
Time Frame: Baseline up to Month 9
|
Baseline up to Month 9
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Blood Pressure Including Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time Frame: Baseline up to Month 9
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Blood pressure (SBP and DBP) will be measured in millimeter of mercury (mmHg).
|
Baseline up to Month 9
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Percentage of Participants who Achieve Clinic DBP Less Than (<) 90 mmHg and/or Reduction of Greater Than or Equal to (>=) 10 mmHg
Time Frame: Baseline up to Month 9
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Baseline up to Month 9
|
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Percentage of Participants who Achieve Clinic SBP <140 mmHg and/or reduction of >=20 mmHg
Time Frame: Baseline up to Month 9
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Baseline up to Month 9
|
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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
Time Frame: Baseline up to Month 9
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Baseline up to Month 9
|
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Change From Baseline in Serum Creatinine Level, Serum Uric Acid Level and Serum Lipid Profile
Time Frame: Baseline up to Month 9
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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
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Change From Baseline in Blood Potassium Level
Time Frame: Baseline up to Month 9
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Blood potassium level will be measured in millimole per liter (mmol/L).
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Baseline up to Month 9
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Change From Baseline in Blood Sodium Profiles
Time Frame: Baseline up to Month 9
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Blood sodium profiles will be measured in milliequivalent per liter (mEq/L).
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Baseline up to Month 9
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Final Effectiveness Rate as Assessed by the Investigator
Time Frame: Baseline up to Month 9
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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".
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Baseline up to Month 9
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Director, Celltrion Pharm, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAK-491-4001
- U1111-1252-3589 (Registry Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Azilsartan Medoxomil
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Arbor Pharmaceuticals, Inc.CompletedHypertensionUnited States, Brazil, Turkey, Poland, Mexico, Colombia, Italy, Argentina, Bulgaria, Hungary, South Africa, Ukraine
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Lee's Pharmaceutical LimitedZhaoke (Guangzhou) Pharmaceutical LimitedCompletedBioequivalence of Two Azilsartan FormulationsHong Kong
-
Research Institute for Complex Problems of Cardiovascular...CompletedDiabetes Mellitus | Arterial Hypertension | Stable Chronic AnginaRussian Federation
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TakedaCompletedEssential HypertensionUnited States, Chile, Mexico
-
TakedaCompletedEssential HypertensionUnited States, Canada