Essential HypertensionPhase 3NCT05526703
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy
A Phase 3 study of Essential Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2022to Oct 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
- Subjects who are 19 years old or older.
- Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.
Who cannot join
- Subjects with a history of secondary hypertension or suspected secondary hypertension
- Subjects who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period
- Subjects with hypersensitivity or history of clinical trial drugs and similar drugs
- Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
- Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
- Subjects who received other clinical trial drugs within 4 weeks of screening visit.
- Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug
- Subjects who are unable to participate in this clinical trial at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, ASI|KR|KS013|SEOUL
Seung Hyuk Choi
About this study
Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy in Essential Hypertension Subjects Inadequately Controlled by D064 Monotherapy
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.
- Conditions
- Essential Hypertension
- Being tested
- D064, D701, placebo of D012, D012, placebo of D064, placebo of D701
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D064, D701, placebo of D012Drug
Also called D064, D701 are consisted of antihypertensive agent.
Experimental Group Subjects assigned to this group are treated with D064, D701, placebo of D012
D012, placebo of D064, placebo of D701Drug
Also called D012 is consisted of antihypertensive agent.
Comparator Group Subjects assigned to this group are treated with D012, placebo of D064, placebo of D701
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: D064, D701, placebo of D012 |
| Comparator Group | Active comparator | Not described Receives: Drug: D012, placebo of D064, placebo of D701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in MSSBP
Compare experimental group with comparator group
Measured: 8 weeks after drug administrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start28 Sep 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
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.
- More trials run by Chong Kun Dang PharmaceuticalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526703
- Sponsor's protocol ID
- A30_14HT2209
- Status last verified
- Nov 2022
- First submitted
- 31 Aug 2022
- Last updated
- 28 Nov 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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy in Essential Hypertension Subjects Inadequately Controlled by D064 Monotherapy
- ClinicalTrials.gov ID
- NCT05526703
- Acronym / sponsor ID
- A30_14HT2209
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 2 Sep 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.
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: D064, D701, placebo of D012 |
| Comparator Group | Active comparator | Drug: D012, placebo of D064, placebo of D701 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who are 19 years old or older.
- Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.
Key exclusion criteria (8 listed)
- Subjects with a history of secondary hypertension or suspected secondary hypertension
- Subjects who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period
- Subjects with hypersensitivity or history of clinical trial drugs and similar drugs
- Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
- Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
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 |
|---|---|---|
| D064, D701, placebo of D012Also: D064, D701 are consisted of antihypertensive agent.Experimental Group Subjects assigned to this group are treated with D064, D701, placebo of D012 | Drug | Experimental Group |
| D012, placebo of D064, placebo of D701Also: D012 is consisted of antihypertensive agent.Comparator Group Subjects assigned to this group are treated with D012, placebo of D064, placebo of D701 | Drug | Comparator Group |
Primary outcome
Change from baseline in MSSBP
Time frame: 8 weeks after drug administrations
Compare experimental group with comparator group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 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.
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 of Essential Hypertension, run by Chong Kun Dang Pharmaceutical 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 8 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: status not confirmed, as of the sponsor's last update on 28 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeonhwa Park, Project Leader (82-2-6373-0636, yeonhwa@ckdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in MSSBP (time frame: 8 weeks after drug administrations). 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 28 Nov 2022.