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Completed

NCT Number: NCT04470830

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

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yeungnam University Medical Center

Daegu, Gyeongsangbuk-do, 42415, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has a SBP or DBP >=140 or 90 mmHg, respectively.
  • 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

  • With anuria.
  • With refractory hypokalemia.
  • 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]).
  • With hyponatremia, hypercalcemia.
  • With symptomatic hyperuricemia (history of gout and urate stone).
  • With untreated Addison's disease.
  • Receiving lithium therapy.
  • Administrating terfenadine and/or astemizole.
  • 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).
  • Participating in a clinical trial evaluating a hypertension treatment.
  • Treated with azilsartan medoxomil / chlorthalidone FDC outside of the locally approved label in South Korea.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants who Experience at Least one AE and SAE

    Time frame: Baseline up to Month 9

Secondary outcomes

  1. 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).

  2. 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

  3. Percentage of Participants who Achieve Clinic SBP <140 mmHg and/or reduction of >=20 mmHg

    Time frame: Baseline up to Month 9

  4. 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

  5. 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).

  6. 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).

  7. 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).

  8. 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".

Sponsors and collaborators

Lead sponsor

Celltrion Pharm, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2020
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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