A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea

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

The purpose of this study is to evaluate the safety by assessing all serious and non-serious adverse events (AEs), irrespective of relatedness or expectedness, as well as other safety parameters including laboratory values, 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
• Conditions: Essential Hypertension

Detailed Description

This is a long-term prospective, observational post-marketing surveillance study of azilsartan medoxomil/chlorthalidone FDC in participants with essential hypertension. The study will assess the safety and effectiveness of azilsartan medoxomil/chlorthalidone FDC prescribed as a monotherapy or taken concomitantly with other anti-hypertension therapies in participants whose blood pressure is not properly controlled by azilsartan medoxomil monotherapy or who require administration of multiple drugs in order to reach the target blood pressure in routine clinical settings.

The study will enroll and will consider approximately 600 participants. These participants will be grouped with the ones treated with azilsartan medoximil monotherpy. 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 (at least 3 months to 6 months) and Visit 4 (6 months or more up to 9 months) after drug administration. The overall duration of the study will be approximately 5 years. All participants will be followed up for 9 months after drug administration.

• Study Type: Observational
• Enrollment (Actual): 718

Contacts and Locations

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

Study Locations

• Korea, Republic of
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of, 42415
      • Yeungnam University Medical Center

Participation Criteria

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 who have administered azilsartan medoxomil/chlorthalidone FDC as an early therapy for participants whose blood pressure is not properly controlled by monotherapy or who require administration of multiple drugs in order to reach the target blood pressure will be observed prospectively.

Description

Inclusion Criteria:

1. Has a SBP or DBP >=140 or 90 mmHg, respectively.
2. Newly prescribed azilsartan medoxomil/chlorthalidone FDC as an early therapy for participants whose blood pressure is not properly controlled by monotherapy with azilsartan medoxomil or who require administration of multiple drugs in order to reach the target blood pressure in participants with stage 2 hypertension.

Exclusion Criteria:

1. With anuria.
2. With refractory hypokalemia.
3. With severe hepatic or renal impairment (estimate glomerular filtration rate [eGFR] <30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2]).
4. With hyponatremia, hypercalcemia.
5. With symptomatic hyperuricemia (history of gout and urate stone).
6. With untreated Addison's disease.
7. Receiving lithium therapy.
8. Administrating terfenadine and/or astemizole.
9. Use of aliskiren in combination with study drug in participants with diabetes or with moderate to severe renal impairment (glomerular filtration rate [GFR] <60 mL/min/1.73m^2).
10. Participating in a clinical trial evaluating a hypertension treatment.
11. Treated with azilsartan medoxomil / chlorthalidone FDC outside of the locally approved label in South Korea.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Participants With Essential Hypertension; Participants diagnosed with essential hypertension who have been treated with azilsartan medoxomil/chlorthalidone FDC as an early therapy for participants whose blood pressure is not properly controlled by monotherapy or who require administration of multiple drugs in order to reach the target blood pressure, will be observed prospectively over a period of 5 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants who Experience at Least one AE and SAE	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)	Blood pressure (SBP and DBP) will be measured in millimeter of mercury (mmHg).	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
Percentage of Participants who Achieve Clinic DBP less than (<) 90 mmHg and/or reduction of Greater than or equal to (>=) 10 mmHg		Baseline up to Month 9

Collaborators and Investigators

• Sponsor: Celltrion Pharm, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• 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

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: TAK-491-5001; U1111-1252-3527 (Registry Identifier: WHO)

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