HypertensionPhase 3NCT02916602
A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
A Phase 3 study testing HCP1401 and HCP0605 in people with Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A phase 3 study to evaluate efficacy and safety of HCP1401 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- HCP1401 and HCP0605
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Sep 2016
- 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
- Hypertension patient who satisfied below condition at Visit 1.
- patient who takes antihypertensive drug
- 140mmHg <= sitSBP <= 200mmHg
- patient who doesn't take antihypertensive drug
- 160mmHg <= sitSBP <= 200mmHg
- 140mmHg <= sitSBP <= 200mmHg at Visit 2
Who cannot join
- Patient who have received 4 or more antihypertensive drug
- Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1
- Patient with sitDBP >= 120mmHg at Visit 2
- Patient with secondary hypertension
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
A phase 3 study to evaluate efficacy and safety of HCP1401
Read the detailed description
A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605
- Conditions
- Hypertension
- Being tested
- HCP1401, HCP0605
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1401Drug
Also called amlodipine, Losartan, Chlorthalidone
amlodipine, Losartan, Chlorthalidone FDC
HCP0605Drug
Also called amlodipine, Losartan
amlodipine, Losartan FDC
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | HCP1401 Receives: Drug: HCP1401 |
| Reference | Active comparator | HCP0605 Receives: Drug: HCP0605 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sitting systolic blood pressure at week 8
Measured: 8 weeks
Secondary outcomes (3)
Change from baseline in sitting diastolic blood pressure at week 2 and week 8
Measured: 2 weeks and 8 weeks
Change from baseline in sitting systolic blood pressure at week 2
Measured: 2 weeks
Proportion of subjects achieving Blood Pressure control
Measured: 2 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startApr 2015
- Primary completionSep 2016
- Study completionSep 2016
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 HypertensionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheulho Kim, M.D.,Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916602
- Sponsor's protocol ID
- HM-ALCH-301
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hong SJ, Jeong HS, Han SH, Chang KY, Hong BK, Lee BK, Chae SC, Kim WS, Park CG, Heo JH, Lee SU, Kim YD, Kim KS, Choi JH, Kang HJ, Kim JJ, Kang SM, Choi YJ, Shin JH, Chun KJ, Shin DG, Park SH, Kwan J, Choi YJ, Jeong MH, Chae JK, Kim DW, Cho JR, Han KR, Won KH, Park SH, Lee SK, Kim SH, Jung J, Kim CH. Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2017 Oct;39(10):2049-2060. doi: 10.1016/j.clinthera.2017.08.013. Epub 2017 Sep 19.
PubMed 28939406
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
- ClinicalTrials.gov ID
- NCT02916602
- Acronym / sponsor ID
- HM-ALCH-301
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Sep 2016 (estimated)
- 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 phase 3 study to evaluate efficacy and safety of HCP1401
Detailed description
A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: HCP1401HCP1401 |
| Reference | Active comparator | Drug: HCP0605HCP0605 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hypertension patient who satisfied below condition at Visit 1.
Key exclusion criteria (4 listed)
- Patient who have received 4 or more antihypertensive drug
- Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1
- Patient with sitDBP >= 120mmHg at Visit 2
- Patient with secondary hypertension
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 |
|---|---|---|
| HCP1401Also: amlodipine, Losartan, Chlorthalidoneamlodipine, Losartan, Chlorthalidone FDC | Drug | Treatment |
| HCP0605Also: amlodipine, Losartanamlodipine, Losartan FDC | Drug | Reference |
Primary outcome
Change from baseline in sitting systolic blood pressure at week 8
Time frame: 8 weeks
3 secondary outcomes
Change from baseline in sitting diastolic blood pressure at week 2 and week 8
Time frame: 2 weeks and 8 weeks
Change from baseline in sitting systolic blood pressure at week 2
Time frame: 2 weeks
Proportion of subjects achieving Blood Pressure control
Time frame: 2 weeks and 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 20 Oct 2016.
- Derived from this study: PubMed 28939406Hong SJ, Jeong HS, Han SH, Chang KY, Hong BK, Lee BK, Chae SC, Kim WS, Park CG, Heo JH, Lee SU, Kim YD, Kim KS, Choi JH, Kang HJ, Kim JJ, Kang SM, Choi YJ, Shin JH, Chun KJ, Shin DG, Park SH, Kwan J, Choi YJ, Jeong MH, Chae JK, Kim DW, Cho JR, Han KR, Won KH, Park SH, Lee SK, Kim SH, Jung J, Kim CH. Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2017 Oct;39(10):2049-2060. doi: 10.1016/j.clinthera.2017.08.013. Epub 2017 Sep 19.
- 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.
Cheulho Kim, M.D.,Ph.D. principal investigator
Seoul National University Bundang Hospital
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 HCP1401 and HCP0605 in people with Hypertension, run by Hanmi Pharmaceutical Company Limited 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 6 inclusion and 4 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 Oct 2016. 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 sitting systolic blood pressure at week 8 (time frame: 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 NCT02916602, 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 20 Oct 2016.