Hypertension (HTN)STRIKENCT07907822
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
An observational study of Hypertension (HTN) and Hypertension, run by Ahn-Gook Pharmaceuticals Co.,Ltd.
Trial summary
This study aims to evaluate the effectiveness, safety, and clinical utility as a treatment strategy of the s-amlodipine-based monotherapy, dual combination, and triple combination in patients with hypertension across various stages of blood pressure control in routine clinical practice. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension (HTN), Hypertension, Essential (Primary) Hypertension
- How many people
- 4,528 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Essential hypertensive patients in need of a monoterapy or combination treatment with S-amlodipinne based antihypertensive agents
Who may be able to join
- Patients who voluntarily consent on the informed consent form and understand the study's purpose, methods, and so on
- Males and females over the age of 19
- Patients who have been diagnosed with essential hypertension and plan to be treated with S- amlodipine or S-amlodipine/Valsartan or S-amlodipine/Valsartan/Indapamide
Who cannot join
- The patients who meet any of the following exclusion criteria cannot participate in this study.
- The patients who are contraindicated for the administration of the study drug according to the approved label
- The patients who are pregnant, possibly pregnant, or lactating women = The patients who are judged by the investigator to be inappropriate for participation in this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective, Observational Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy in Korean Hypertensive Patients
This study aims to evaluate the effectiveness, safety, and clinical utility as a treatment strategy of the s-amlodipine-based monotherapy, dual combination, and triple combination in patients with hypertension across various stages of blood pressure control in routine clinical practice.
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy cohort | Not described | |
| Combination therapy cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood pressure control rate
The blood pressure control rate (< 140/90 mmHg)(Systolic and Diastolic) at Week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hae-Young Lee, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907822
- Sponsor's protocol ID
- Levofamily_OS
- Acronym
- STRIKE
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy in Korean Hypertensive Patients
- ClinicalTrials.gov ID
- NCT07907822
- Acronym / sponsor ID
- STRIKE / Levofamily_OS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,528 participants (estimated)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 30 Oct 2026 (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 aims to evaluate the effectiveness, safety, and clinical utility as a treatment strategy of the s-amlodipine-based monotherapy, dual combination, and triple combination in patients with hypertension across various stages of blood pressure control in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy cohort | – | – |
| Combination therapy cohort | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Essential hypertensive patients in need of a monoterapy or combination treatment with S-amlodipinne based antihypertensive agents
Key inclusion criteria (3 listed)
- Patients who voluntarily consent on the informed consent form and understand the study's purpose, methods, and so on
- Males and females over the age of 19
- Patients who have been diagnosed with essential hypertension and plan to be treated with S- amlodipine or S-amlodipine/Valsartan or S-amlodipine/Valsartan/Indapamide
Key exclusion criteria (3 listed)
- The patients who meet any of the following exclusion criteria cannot participate in this study.
- The patients who are contraindicated for the administration of the study drug according to the approved label
- The patients who are pregnant, possibly pregnant, or lactating women = The patients who are judged by the investigator to be inappropriate for participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The blood pressure control rate
Time frame: Week 12
The blood pressure control rate (< 140/90 mmHg)(Systolic and Diastolic) at Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.
Hae-Young Lee principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension (HTN) and Hypertension, run by Ahn-Gook Pharmaceuticals Co.,Ltd.
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 3 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyunji Kim (82-2-3289-4215, hyunji.kim@ahn-gook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The blood pressure control rate (time frame: Week 12). 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 30 Oct 2026.