HypertensionPhase 4NCT04521023
A Clinical Trial to Evaluate the Blood Pressure Lowering Effect of a Candemore Plus Tab Versus Cantabell Tab in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
A Phase 4 study testing Cantabell Tab and Candemore Plus Tab in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 14 sites in South Korea.
Trial summary
Phase 4 clinical trial to Evaluate the blood pressure lowering effect of a Candesartan/Hydrochlorothiazide(Candemore Plus Tab) versus Candesartan/Amlodipine(Cantabell Tab) in Hypertensive Patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Cantabell Tab and Candemore Plus Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 20 Sep 2017to 3 Jun 2020
- Phase
- Phase 4
- 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
- over 19 years old
- Agreement with written informed consent
- Hypertensive Patients
Who cannot join
- Patients with secondary hypertension
- Participated in other trial within 30 days
- In investigator's judgement
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Hallym Univ. Medical Center
Anyang
Daegu Catholic Univ. Medical Center
Daegu
MYONGJI Hospital
Goyang-si
Inje University Ilsan Paik Hospital
Ilsan-gu
Gachon University Gil Medical Center
Incheon
Jeju National University Hospital
Jeju City
Gangnam Severance Hospital
Seoul
Hallym University Kangnam Sacred Heart Hospital
Seoul
Hanyang University Medical Center
Seoul
Kangbuk Samsung Hospital
Seoul
SNU Boramae Medical Center
Seoul
Ajou University Hospital
Suwon, Gyeonggi-do
Ulsan University Hospital
Ulsan
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: A Randomized, Double-blind, Non-inferiority, Multi-center, Phase 4 Trial to Evaluate the Blood Pressure Lowering Effect of a Candesartan/Hydrochlorothiazide(Candemore Plus® Tab) Versus Candesartan/Amlodipine(Cantabell® Tab) in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
Phase 4 clinical trial to Evaluate the blood pressure lowering effect of a Candesartan/Hydrochlorothiazide(Candemore Plus Tab) versus Candesartan/Amlodipine(Cantabell Tab) in Hypertensive Patients
- Conditions
- Hypertension
- Being tested
- Cantabell Tab, Candemore Plus Tab
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cantabell TabDrug
Patients assigned to experimental group are treated with Cantabell Tab
Candemore Plus TabDrug
Patients assigned to experimental group are treated with Candemore Plus Tab
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Cantabell Tab |
| B | Active comparator | Not described Receives: Drug: Candemore Plus Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
cSBP(central Systolic Blood Pressure)
Average cSBP change after 8 weeks compared to baseline
Measured: change after 8 weeks compared to baseline
Secondary outcomes (3)
cDBP(central Diastolic Blood Pressure)
Average cDBP change after 8 weeks compared to baseline
Measured: change after 8 weeks compared to baseline
sitSBP(sitting Systolic Blood Pressure)
Average sitSBP change after 8 weeks compared to baseline
Measured: change after 8 weeks compared to baseline
sitDBP(sitting Diastolic Blood Pressure)
Average sitDBP change after 8 weeks compared to baseline
Measured: change after 8 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start20 Sep 2017
- Primary completion28 Jan 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
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
- NCT04521023
- Sponsor's protocol ID
- 244HT16025
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 20 Aug 2020
- 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 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Non-inferiority, Multi-center, Phase 4 Trial to Evaluate the Blood Pressure Lowering Effect of a Candesartan/Hydrochlorothiazide(Candemore Plus® Tab) Versus Candesartan/Amlodipine(Cantabell® Tab) in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
- ClinicalTrials.gov ID
- NCT04521023
- Acronym / sponsor ID
- 244HT16025
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 20 Aug 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.
Phase 4 clinical trial to Evaluate the blood pressure lowering effect of a Candesartan/Hydrochlorothiazide(Candemore Plus Tab) versus Candesartan/Amlodipine(Cantabell Tab) in Hypertensive Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Cantabell Tab |
| B | Active comparator | Drug: Candemore Plus Tab |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 19 years old
- Agreement with written informed consent
- Hypertensive Patients
Key exclusion criteria (3 listed)
- Patients with secondary hypertension
- Participated in other trial within 30 days
- In investigator's judgement
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 |
|---|---|---|
| Cantabell TabPatients assigned to experimental group are treated with Cantabell Tab | Drug | A |
| Candemore Plus TabPatients assigned to experimental group are treated with Candemore Plus Tab | Drug | B |
Primary outcome
cSBP(central Systolic Blood Pressure)
Time frame: change after 8 weeks compared to baseline
Average cSBP change after 8 weeks compared to baseline
3 secondary outcomes
cDBP(central Diastolic Blood Pressure)
Time frame: change after 8 weeks compared to baseline
sitSBP(sitting Systolic Blood Pressure)
Time frame: change after 8 weeks compared to baseline
sitDBP(sitting Diastolic Blood Pressure)
Time frame: change after 8 weeks compared to baseline
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 20 Aug 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cantabell Tab and Candemore Plus Tab in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 14 sites 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 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: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
cSBP(central Systolic Blood Pressure) (time frame: change after 8 weeks compared to baseline). 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 20 Aug 2020.