Essential HypertensionPhase 2NCT04488978
Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension
A Phase 2 study testing Irbesartan/Amlodipine in people with Essential Hypertension, run by Handok Inc. at 1 site in South Korea.
Trial summary
A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Irbesartan/Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2020to 9 Nov 2021
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 19 years or older / 75 years or younger on screening
- Signed informed consent
- Patients with Essential Hypertension
- Other inclusion applied
Who cannot join
- Orthostatic hypertension with symptom
- Other exclusion applied
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul, 03722
About this study
Official title: A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
- Conditions
- Essential Hypertension
- Being tested
- Irbesartan/Amlodipine
- 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
QID
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan low/Amlodipine low | Experimental | Irbesartan low \& Amlodipine low, once daily for 8 weeks Receives: Drug: Irbesartan/Amlodipine |
| Irbesartan low/Amlodipine high | Experimental | Irbesartan low \& Amlodipine high, once daily for 8 weeks Receives: Drug: Irbesartan/Amlodipine |
| Irbesartan high/Amlodipine low | Experimental | Irbesartan high \& Amlodipine low, once daily for 8 weeks Receives: Drug: Irbesartan/Amlodipine |
| Irbesartan high/Amlodipine high | Experimental | Irbesartan high \& Amlodipine high, once daily for 8 weeks Receives: Drug: Irbesartan/Amlodipine |
| Amlodipine low | Active comparator | Amlodipine low, once daily for 8 weeks Receives: Drug: Irbesartan/Amlodipine |
| Amlodipine high | Active comparator | Amlodipine high, once daily for 8 weeks Receives: Drug: Irbesartan/Amlodipine |
| Irbesartan low | Active comparator | Irbesartan low, once daily for 8 weeks Receives: Drug: Irbesartan/Amlodipine |
| Irbesartan high | Active comparator | Irbesartan high, once daily for 8 weeks Receives: Drug: Irbesartan/Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in MSSBP between baseline and Week8.
The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.
Measured: Baseline and Week8
Secondary outcomes (3)
The change in MSSBP between baseline and Week4.
Measured: Baseline and Week4
The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.
Measured: Baseline and Week4/8
The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.
Measured: Baseline and Week4/8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start21 May 2020
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 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
- NCT04488978
- Sponsor's protocol ID
- AI-C201
- Status last verified
- Jun 2022
- First submitted
- 21 Jul 2020
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT04488978
- Acronym / sponsor ID
- AI-C201
- Conditions
- Essential Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2020 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 28 Jul 2020 (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.
A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Irbesartan low/Amlodipine low | Experimental | Drug: Irbesartan/AmlodipineIrbesartan low \& Amlodipine low, once daily for 8 weeks |
| Irbesartan low/Amlodipine high | Experimental | Drug: Irbesartan/AmlodipineIrbesartan low \& Amlodipine high, once daily for 8 weeks |
| Irbesartan high/Amlodipine low | Experimental | Drug: Irbesartan/AmlodipineIrbesartan high \& Amlodipine low, once daily for 8 weeks |
| Irbesartan high/Amlodipine high | Experimental | Drug: Irbesartan/AmlodipineIrbesartan high \& Amlodipine high, once daily for 8 weeks |
| Amlodipine low | Active comparator | Drug: Irbesartan/AmlodipineAmlodipine low, once daily for 8 weeks |
| Amlodipine high | Active comparator | Drug: Irbesartan/AmlodipineAmlodipine high, once daily for 8 weeks |
| Irbesartan low | Active comparator | Drug: Irbesartan/AmlodipineIrbesartan low, once daily for 8 weeks |
| Irbesartan high | Active comparator | Drug: Irbesartan/AmlodipineIrbesartan high, once daily for 8 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 19 years or older / 75 years or younger on screening
- Signed informed consent
- Patients with Essential Hypertension
- Other inclusion applied
Key exclusion criteria (2 listed)
- Orthostatic hypertension 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/AmlodipineQID | Drug | Amlodipine high, Amlodipine low, Irbesartan high, Irbesartan high/Amlodipine high, Irbesartan high/Amlodipine low, Irbesartan low, Irbesartan low/Amlodipine high, Irbesartan low/Amlodipine low |
Primary outcome
The change in MSSBP between baseline and Week8.
Time frame: Baseline and Week8
The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.
3 secondary outcomes
The change in MSSBP between baseline and Week4.
Time frame: Baseline and Week4
The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.
Time frame: Baseline and Week4/8
The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.
Time frame: Baseline and Week4/8
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 30 Jun 2022.
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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 2 study testing Irbesartan/Amlodipine 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 30 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The change in MSSBP between baseline and Week8. (time frame: Baseline and Week8). 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 Jun 2022.