NCT04470817

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,438

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

4.8 years

First QC Date

July 13, 2020

Last Update Submit

October 25, 2023

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

  • +3 more secondary outcomes

Study Arms (1)

Participants With Essential Hypertension

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, will be observed prospectively over a period of 6 years.

Drug: Azilsartan Medoxomil

Interventions

Azilsartan MedoxomilDRUG

Azilsartan Medoxomil

Participants With Essential Hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • Newly prescribed and initiates azilsartan medoxomil for the treatment of hypertension, as a monotherapy or taken concomitantly with other anti-hypertension therapies.

You may not qualify if:

  • Treated with azilsartan medoxomil outside of the locally approved label in South Korea.
  • With known hypersensitivity or presence of any contraindication to azilsartan medoxomil.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Myongji Hospital

Goyang-si, Gyeonggi-do, 10475, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

azilsartan medoxomil

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Medical Director

    Celltrion Pharm, Inc.

    STUDY DIRECTOR

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

August 7, 2018

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

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.

Locations

KR(1)