NCT05450575

Brief Summary

This study was to evaluate the therapeutic effect and safety of amosartan Q tablet administration in adult patients with hypertension and dyslipidemia. During the routine medical visit, Amosartan Q tablets were administered to patients in need of blood pressure/LDL-C control according to the investigator's judgment. In this study, effectiveness and safety information of treatment of Amosartan Q tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data. As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

3.3 years

First QC Date

July 5, 2022

Last Update Submit

July 5, 2022

Conditions

HypertensionDyslipidemia

Keywords

AmosartanHypertensionDyslipidemiaObservational

Outcome Measures

Primary Outcomes (2)

  • percentage(%) of patients who achieved target blood pressure

    6 months

  • percentage(%) of patients who achieved target LDL-C

    6 months

Study Arms (1)

single arm, single group(No interventional)

Observational

Drug: Amosartan Q tablet

Interventions

Amosartan Q tabletDRUG

Amlodipine, Losartan, Rosuvastatin

Also known as: amosartan Q
single arm, single group(No interventional)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have hypertension and dyslipidemia

You may qualify if:

  • Patients with hypertension and dyslipidemia
  • Those who have already decided to administer Amosartan Q tablet under the medical judgment of the researcher
  • Those who voluntarily decided to participate in this study and consented in writing to the consent form

You may not qualify if:

  • Patients for whom use of Amosartan Q tablet is prohibited

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi Pharmaceutical Company Limited

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 8, 2022

Study Start

April 17, 2018

Primary Completion

July 20, 2021

Study Completion

July 20, 2021

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)