Essential HypertensionPhase 3NCT05475665
Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients
A Phase 3 study testing Irbesartan/Amlodipine and Irbesartan in people with Essential Hypertension, run by Handok Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Irbesartan/Amlodipine and Irbesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2022to 13 Jun 2023
- Phase
- Phase 3
- 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
Who may be able to join
- Patients who are 19 years or older on screening
- Signed informed consent
- Patients with Essential Hypertension
- Other inclusion applied
Who cannot join
- Orthostatic hypotension with symptom
- Other exclusion applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase # Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy
- Conditions
- Essential Hypertension
- Being tested
- Irbesartan/Amlodipine, Irbesartan
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irbesartan/AmlodipineDrug
Irbesartan/Amlodipine once daily for 8 weeks
IrbesartanDrug
Irbesartan once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan/Amlodipine | Experimental | Not described Receives: Drug: Irbesartan/Amlodipine |
| Irbesartan | Active comparator | Not described Receives: Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean sitting systolic blood pressure (mmHg)
Measured: Week 8
Secondary outcomes (4)
Change form baseline in mean sitting systolic blood pressure (mmHg)
Measured: Week 4
Change form baseline in mean sitting diastolic blood pressure (mmHg)
Measured: Week 4, 8
Responder rate
Measured: Week 4, 8
Target blood pressure reach rate
Measured: Week 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start14 Jul 2022
- Primary completion30 Mar 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475665
- Sponsor's protocol ID
- HD-AI-302
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee HY, Min KW, Han KA, Kim JS, Ahn JC, Kim MH, Lee JB, Shin SH, Kim CJ, Kim KH, Cho DK, Choi J, Rhee MY, Her SH, Kim W, Na JO, Cho GY, Kim SY, Park GM, Lee BK, Jo SH, Lee BW, Sohn IS, Kim DI, Ihm SH, Lee SH, Chung JW, Cho EJ, Son JW, Oh SJ, Hwang JY, Jeong JO, Han KR, Yoon HJ, Seo SM, Chung WJ, Bae JW, Choi JH, Hyun BJ, Cha JE, Yoo SJ, Shin J. The Efficacy and Tolerability of Irbesartan/Amlodipine Combination Therapy in Patients With Essential Hypertension Whose Blood Pressure Were not Controlled by Irbesartan Monotherapy. Clin Ther. 2024 Jun;46(6):481-489. doi: 10.1016/j.clinthera.2024.04.004. Epub 2024 May 3.
PubMed 38704294
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase # Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
- ClinicalTrials.gov ID
- NCT05475665
- Acronym / sponsor ID
- HD-AI-302
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 27 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.
The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irbesartan/Amlodipine | Experimental | Drug: Irbesartan/Amlodipine |
| Irbesartan | Active comparator | Drug: Irbesartan |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 19 years or older on screening
- Signed informed consent
- Patients with Essential Hypertension
- Other inclusion applied
Key exclusion criteria (2 listed)
- Orthostatic hypotension with symptom
- Other exclusion applied
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 |
|---|---|---|
| Irbesartan/AmlodipineIrbesartan/Amlodipine once daily for 8 weeks | Drug | Irbesartan/Amlodipine |
| IrbesartanIrbesartan once daily for 8 weeks | Drug | Irbesartan |
Primary outcome
Change from baseline in mean sitting systolic blood pressure (mmHg)
Time frame: Week 8
4 secondary outcomes
Change form baseline in mean sitting systolic blood pressure (mmHg)
Time frame: Week 4
Change form baseline in mean sitting diastolic blood pressure (mmHg)
Time frame: Week 4, 8
Responder rate
Time frame: Week 4, 8
Target blood pressure reach rate
Time frame: Week 4, 8
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 18 Aug 2023.
- Derived from this study: PubMed 38704294Lee HY, Min KW, Han KA, Kim JS, Ahn JC, Kim MH, Lee JB, Shin SH, Kim CJ, Kim KH, Cho DK, Choi J, Rhee MY, Her SH, Kim W, Na JO, Cho GY, Kim SY, Park GM, Lee BK, Jo SH, Lee BW, Sohn IS, Kim DI, Ihm SH, Lee SH, Chung JW, Cho EJ, Son JW, Oh SJ, Hwang JY, Jeong JO, Han KR, Yoon HJ, Seo SM, Chung WJ, Bae JW, Choi JH, Hyun BJ, Cha JE, Yoo SJ, Shin J. The Efficacy and Tolerability of Irbesartan/Amlodipine Combination Therapy in Patients With Essential Hypertension Whose Blood Pressure Were not Controlled by Irbesartan Monotherapy. Clin Ther. 2024 Jun;46(6):481-489. doi: 10.1016/j.clinthera.2024.04.004. Epub 2024 May 3.
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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?
A Phase 3 study testing Irbesartan/Amlodipine and Irbesartan in people with Essential Hypertension, run by Handok Inc. 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 4 inclusion and 2 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 18 Aug 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in mean sitting systolic blood pressure (mmHg) (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475665, which also lists 1 linked publication.
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 18 Aug 2023.