A Study for PMS of AZL-M in the Treatment of Adult Participants With Essential Hypertension in South Korea

October 25, 2023 updated by: Celltrion Pharm, Inc.

Post-Marketing Surveillance (Usage Results Study) of Azilsartan Medoxomil in the Treatment of Adult Patients With Essential Hypertension in South Korea

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).

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

3438

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Takeda Study Registration Call Center
  • Phone Number: 1-877-825-3327
  • Email: medinfoUS@takeda.com

Study Locations

    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10475
        • Myongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  1. 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.
  2. Newly prescribed and initiates azilsartan medoxomil for the treatment of hypertension, as a monotherapy or taken concomitantly with other anti-hypertension therapies.

Exclusion Criteria:

  1. Treated with azilsartan medoxomil outside of the locally approved label in South Korea.
  2. With known hypersensitivity or presence of any contraindication to azilsartan medoxomil.
  3. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Azilsartan Medoxomil

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

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
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
Time Frame: Baseline up to Month 9
Baseline up to Month 9
Percentage of Participants who Achieve Clinic SBP <140 mmHg and/or reduction of >=20 mmHg
Time Frame: Baseline up to Month 9
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
Time Frame: Baseline up to Month 9
Baseline up to Month 9
Change From Baseline in Serum Creatinine Level, Serum Uric Acid Level and Serum Lipid Profile
Time Frame: Baseline up to Month 9
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
Time Frame: Baseline up to Month 9
Blood potassium level will be measured in millimole per liter (mmol/L).
Baseline up to Month 9
Change From Baseline in Blood Sodium Profiles
Time Frame: Baseline up to Month 9
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
Time Frame: Baseline up to Month 9
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Medical Director, Celltrion Pharm, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2018

Primary Completion (Actual)

May 25, 2023

Study Completion (Actual)

May 25, 2023

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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