An Observational Study to Evaluate Effectiveness and Safety of Amosartan Plus Tablet

NCT05462535 | Completed

• 1 other identifier: HM-AMOP-OS-01
• Study Type: observational
• Target: 4,785
• Locations: 1 country
• Sites: 1

Brief Summary

This study was to evaluate the therapeutic effect and safety of Amosartan Plus tablet administration in uncontrolled essential hypertension patients. During the routine medical visit, Amosartan Plus tablets were administered to patients in need of blood pressure control according to the investigator's judgment. In this study, effectiveness and safety information of treatment of Amosartan Plus 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.

Conditions

Hypertension,Essential

Outcome Measures

Primary Outcomes (3)

• Change from baseline in SBP/DBP

  24 weeks

• Percentage from baseline in SBP/DBP

  24 weeks

• Percentage of patients achieving target blood pressure

  24 weeks

Study Arms (1)

Single arm, Single group(No interventional)

Observational

Drug: Amosartan Plus Tab.

Interventions

Amosartan Plus Tab. DRUG

Amosartan Plus Tab., Once daily administered per the locally approved product information

Also known as: Amlodipine camsylate, Losartan potassium, Chlorthalidone

Single arm, Single group(No interventional)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Uncontrolled essential hypertension patients

You may qualify if:

• Uncontrolled essential hypertension patients
• Those who have already decided to administer Amosartan Plus 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 Plus tablet is prohibited

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Tablets; Losartan; Chlorthalidone

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Benzenesulfonamides; Sulfonamides; Amides; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

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

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: February 26, 2018
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

KR (1)