Clinical trial NCT04470830: A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
Official title: Post-Marketing Surveillance (Usage Results Study) of Azilsartan Medoxomil/Chlorthalidone FDC in the Treatment of 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: 718
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 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.

Brief summary: 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).

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.

Eligibility criteria: 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.

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: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
state: Gyeongsangbuk-do
Study officials:
References: