Clinical trial NCT04470817: A Study for PMS of AZL-M in the Treatment of Adult Participants With Essential Hypertension in South Korea
Official title: Post-Marketing Surveillance (Usage Results Study) of Azilsartan Medoxomil in the Treatment of Adult Patients With Essential Hypertension in South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Keywords: Drug Therapy
Lead sponsor: Celltrion Pharm, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 3438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants who Experience at Least one AE and SAE
timeFrame: Baseline up to Month 9
Secondary outcomes:
measure: Change From Baseline in Blood Pressure Including Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
timeFrame: Baseline up to Month 9
measure: Percentage of Participants who Achieve Clinic DBP Less Than (<) 90 mmHg and/or Reduction of Greater Than or Equal to (>=) 10 mmHg
timeFrame: Baseline up to Month 9
measure: Percentage of Participants who Achieve Clinic SBP <140 mmHg and/or reduction of >=20 mmHg
timeFrame: Baseline up to Month 9
measure: 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
timeFrame: Baseline up to Month 9
measure: Change From Baseline in Serum Creatinine Level, Serum Uric Acid Level and Serum Lipid Profile
timeFrame: Baseline up to Month 9
measure: Change From Baseline in Blood Potassium Level
timeFrame: Baseline up to Month 9
measure: Change From Baseline in Blood Sodium Profiles
timeFrame: Baseline up to Month 9
measure: Final Effectiveness Rate as Assessed by the Investigator
timeFrame: Baseline up to Month 9
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi-do
Study officials:
affiliation: Celltrion Pharm, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: