HypertensionNCT05450575
An Observational Study to Evaluate Effectiveness and Safety of Amosartan Q Tablet
An observational study of Hypertension and Dyslipidemia, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Amosartan Q tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 5,400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Apr 2018to 20 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have hypertension and dyslipidemia
Who may be able to join
- 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
Who cannot join
- Patients for whom use of Amosartan Q tablet is prohibited
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational Study of Factors Affecting Blood Pressure and Blood Lipids After Treatment With Amosartan Q Tablet in Hypertension Patients With Dyslipidemia
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.
Read the detailed description
This study was a multicenter, prospective, non-interventional, observational study of factors affecting blood pressure and blood lipids after treatment with Amosartan Q tablet in hypertension patients with dyslipidemia.
Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Q tablet.
This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Amosartan Q tablet
- Keywords
- Amosartan, Hypertension, Dyslipidemia, Observational
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amosartan Q tabletDrug
Also called amosartan Q
Amlodipine, Losartan, Rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| single arm, single group(No interventional) | Observational Receives: Drug: Amosartan Q tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage(%) of patients who achieved target blood pressure
Measured: 6 months
percentage(%) of patients who achieved target LDL-C
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start17 Apr 2018
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450575
- Sponsor's protocol ID
- HM-AMOQ-OS-01
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study of Factors Affecting Blood Pressure and Blood Lipids After Treatment With Amosartan Q Tablet in Hypertension Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT05450575
- Acronym / sponsor ID
- HM-AMOQ-OS-01
- Conditions
- Hypertension, Dyslipidemia
- Keywords
- Amosartan, Hypertension, Dyslipidemia, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,400 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was a multicenter, prospective, non-interventional, observational study of factors affecting blood pressure and blood lipids after treatment with Amosartan Q tablet in hypertension patients with dyslipidemia.
Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Q tablet.
This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm, single group(No interventional) | – | Drug: Amosartan Q tabletObservational |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have hypertension and dyslipidemia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients for whom use of Amosartan Q tablet is prohibited
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amosartan Q tabletAlso: amosartan QAmlodipine, Losartan, Rosuvastatin | Drug | single arm, single group(No interventional) |
Primary outcome
percentage(%) of patients who achieved target blood pressure
Time frame: 6 months
percentage(%) of patients who achieved target LDL-C
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Dyslipidemia, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage(%) of patients who achieved target blood pressure (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.