Hypertension,EssentialPhase 2NCT04218552
Determining the Optimal Dose of AD-209 in Patients With Essential Hypertension
A Phase 2 study testing AD209, Amlodipine low and Amlodipine high in people with Hypertension,Essential, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the optimal dose of AD-209 in patients with Essential Hypertension. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- AD209, Amlodipine low and Amlodipine high
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Feb 2020to 25 Feb 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Other inclusions applied
Who cannot join
- orthostatic hypotension with symptom
- Other exclusions applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-209 in Patients With Essential Hypertension
The purpose of this study is to determine the optimal dose of AD-209 in patients with Essential Hypertension.
Read the detailed description
Condition or disease : hypertension Intervention/treatment Drug : AD-209-H Drug : AD-209-M Drug : AD-209-L Drug : Placebo Drug : Amlodipine Drug : Telmisartan Phase : Phase 2
- Conditions
- Hypertension,Essential
- Being tested
- AD209, Amlodipine low, Amlodipine high, Telmisartan
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD209Drug
Also called AD209 Placebo
PO, Once daily(QD), 8weeks
Amlodipine lowDrug
Also called Amlodipine low placebo
PO, Once daily(QD), 8weeks
Amlodipine highDrug
Also called Amlodipine high placebo
PO, Once daily(QD), 8weeks
TelmisartanDrug
Also called Telmisartan placebo
PO, Once daily(QD), 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | AD-209 High Receives: Drug: AD209 |
| Experimental 2 | Experimental | AD-209 Middle Receives: Drug: AD209 |
| Experimental 3 | Experimental | AD-209 Low Receives: Drug: AD209 |
| Active Comparator 1 | Active comparator | Amlodipine Low Receives: Drug: Amlodipine low |
| Active Comparator 2 | Active comparator | Amlodipine High Receives: Drug: Amlodipine high |
| Active Comparator 3 | Active comparator | Telmisartan Receives: Drug: Telmisartan |
| Placebo comparator | Placebo comparator | Placebo Receives: Drug: AD209; Drug: Amlodipine low; Drug: Amlodipine high; Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change rate of MSSBP
Change from baseline in mean sitting systolic blood pressure
Measured: [ Time Frame: baseline, 8 weeks ]
Secondary outcomes (4)
1. Change rate of MSSBP
Change from baseline in mean sitting systolic blood pressure
Measured: [ Time Frame: baseline, 4 weeks ]
2. Change rate of MSDBP
Change from baseline in mean sitting diastolic blood pressure
Measured: [ Time Frame: baseline, 4 weeks, 8 weeks ]
3. Proportion of BP normalization MSSBP/MSDBP < 140/90 mmHg MSSBP/MSDBP < 130/80 mmHg (Diabetes or Chronic renal disease)
Proportion of subjects achieving blood pressure control
Measured: [ Time Frame: 4 weeks, 8 weeks ]
4.Reaction rate of BP
Proportion of reduction from baseline in MSSBP/MSDBP ≥ 20/10 mmHg
Measured: [ Time Frame: baseline, 4 weeks, 8 weeks ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start25 Feb 2020
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
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 Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ChangGu Park, M.D., Ph.D, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218552
- Sponsor's protocol ID
- AD-209P2
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung KC, Sung JH, Cho EJ, Ahn JC, Han SH, Kim W, Kim KH, Sohn IS, Shin J, Kim SY, Kim KI, Kang SM, Park SJ, Kim YJ, Shin JH, Park SM, Park CG. Efficacy and safety of low-dose antihypertensive combination of amlodipine, telmisartan, and chlorthalidone: A randomized, double-blind, parallel, phase II trial. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1298-1309. doi: 10.1111/jch.14570. Epub 2022 Sep 12.
PubMed 36094783
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-209 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT04218552
- Acronym / sponsor ID
- AD-209P2
- Conditions
- Hypertension,Essential
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 6 Jan 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.
The purpose of this study is to determine the optimal dose of AD-209 in patients with Essential Hypertension.
Detailed description
Condition or disease : hypertension Intervention/treatment Drug : AD-209-H Drug : AD-209-M Drug : AD-209-L Drug : Placebo Drug : Amlodipine Drug : Telmisartan Phase : Phase 2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: AD209AD-209 High |
| Experimental 2 | Experimental | Drug: AD209AD-209 Middle |
| Experimental 3 | Experimental | Drug: AD209AD-209 Low |
| Active Comparator 1 | Active comparator | Drug: Amlodipine lowAmlodipine Low |
| Active Comparator 2 | Active comparator | Drug: Amlodipine highAmlodipine High |
| Active Comparator 3 | Active comparator | Drug: TelmisartanTelmisartan |
| Placebo comparator | Placebo comparator | Drug: AD209, Drug: Amlodipine low, Drug: Amlodipine high, Drug: TelmisartanPlacebo |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Other inclusions applied
Key exclusion criteria (2 listed)
- orthostatic hypotension with symptom
- Other exclusions 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 |
|---|---|---|
| AD209Also: AD209 PlaceboPO, Once daily(QD), 8weeks | Drug | Experimental 1, Experimental 2, Experimental 3, Placebo comparator |
| Amlodipine lowAlso: Amlodipine low placeboPO, Once daily(QD), 8weeks | Drug | Active Comparator 1, Placebo comparator |
| Amlodipine highAlso: Amlodipine high placeboPO, Once daily(QD), 8weeks | Drug | Active Comparator 2, Placebo comparator |
| TelmisartanAlso: Telmisartan placeboPO, Once daily(QD), 8weeks | Drug | Active Comparator 3, Placebo comparator |
Primary outcome
1. Change rate of MSSBP
Time frame: [ Time Frame: baseline, 8 weeks ]
Change from baseline in mean sitting systolic blood pressure
4 secondary outcomes
1. Change rate of MSSBP
Time frame: [ Time Frame: baseline, 4 weeks ]
2. Change rate of MSDBP
Time frame: [ Time Frame: baseline, 4 weeks, 8 weeks ]
3. Proportion of BP normalization MSSBP/MSDBP < 140/90 mmHg MSSBP/MSDBP < 130/80 mmHg (Diabetes or Chronic renal disease)
Time frame: [ Time Frame: 4 weeks, 8 weeks ]
4.Reaction rate of BP
Time frame: [ Time Frame: baseline, 4 weeks, 8 weeks ]
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 21 Jul 2021.
- Derived from this study: PubMed 36094783Sung KC, Sung JH, Cho EJ, Ahn JC, Han SH, Kim W, Kim KH, Sohn IS, Shin J, Kim SY, Kim KI, Kang SM, Park SJ, Kim YJ, Shin JH, Park SM, Park CG. Efficacy and safety of low-dose antihypertensive combination of amlodipine, telmisartan, and chlorthalidone: A randomized, double-blind, parallel, phase II trial. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1298-1309. doi: 10.1111/jch.14570. Epub 2022 Sep 12.
- 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.
ChangGu Park, M.D., Ph.D principal investigator
Korea University Guro Hospital
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 AD209, Amlodipine low and Amlodipine high in people with Hypertension,Essential, run by Addpharma 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 2 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 21 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
1. Change rate of MSSBP (time frame: [ Time Frame: baseline, 8 weeks ]). 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 NCT04218552, 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 21 Jul 2021.