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

NCT04470830 | Completed

• 2 other identifiers: TAK-491-5001U1111-1252-3527
• Study Type: observational
• Target: 718
• Locations: 1 country
• Sites: 1

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).

Conditions

Essential Hypertension

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Experience at Least one AE and SAE

  Baseline up to Month 9

Secondary Outcomes (8)

• Change From Baseline in Blood Pressure Including Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

  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

• 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

  Baseline up to Month 9

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celltrion Pharm, Inc.: lead

Study Sites (1)

Yeungnam University Medical Center

Daegu, Gyeongsangbuk-do, 42415, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 14, 2020
• Study Start: September 11, 2019
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)