HypertensionPhase 3NCT04074551
A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
A Phase 3 study testing HCP1701, Losartan and Amlodipine in people with Hypertension and Dyslipidemias, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Dyslipidemias
- What is being tested?
- HCP1701, Losartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jul 2019to 17 Mar 2020
- 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
- Age ≥ 19
- Patients who understood the contents and purpose of this trial and signed informed consent form
- Patients with essential hypertension and dyslipidemia
Who cannot join
- Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
- Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
- Concomitant administration of cyclosporine
- Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
- Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers
- Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
Show all 20Show fewer
- CPK normal range > 2 times
- Secondary hypertension and suspected secondary hypertension
- Orthostatic hypotension with symptoms
- Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
- Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
- Active gout or hyperuricemia(uric acid ≥ 9mg/dL)
- IDDM or uncontrolled type 2 diabetes mellitus (HbA1c > 9%)
- Ventricular arrhythmia
- Medical history
- Severe heart disease(heart failure of NYHA class III-IV)
- Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA)
- Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve
- Ischemic heart disease(myocardial infarction, angina) within 6months
- Angioplasty or coronary artery bypass graft(CABG) surgery within 6months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia
- Conditions
- Hypertension, Dyslipidemias
- Being tested
- HCP1701, Losartan, Amlodipine, Rosuvastatin and Ezetimibe
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1701Drug
HCP1701
LosartanDrug
Losartan
AmlodipineDrug
Amlodipine
Rosuvastatin and EzetimibeDrug
Rosuvastatin and Ezetimibe
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | HCP1701 Receives: Drug: HCP1701 |
| Active Comparator 1 | Active comparator | HGP0904, HGP0608 Receives: Drug: Losartan; Drug: Amlodipine |
| Active Comparator 2 | Active comparator | HGP0608, HCP1306 Receives: Drug: Losartan; Drug: Rosuvastatin and Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in LDL-C (%)
Experimental, Active Control 1
Measured: baseline, 8 weeks
Change from baseline in sitting systolic blood pressure
Experimental, Active Control 2
Measured: baseline, 8 weeks
Secondary outcomes (10)
Change from baseline in LDL-C (%)
Experimental, Active Control 2
Measured: baseline, 8 weeks
Change from baseline in sitting systolic blood pressure
Experimental, Active Control 1
Measured: baseline, 8 weeks
Change from baseline in LDL-C (%)
Measured: baseline, 4 weeks
Change from baseline in sitting systolic blood pressure
Measured: baseline, 4 weeks
Change from baseline in TC, HDL-C, TG (%)
Measured: baseline, 4 weeks, 8 weeks
Change from baseline in sitting distolic blood pressure
Measured: baseline, 4 weeks, 8 weeks
Proportion of subject achieving LDL-C control
Measured: baseline, 4 weeks, 8 weeks
Proportion of subjects achieving blood pressure control
Measured: baseline, 4 weeks, 8 weeks
Proportion of responder for blood pressure
Measured: baseline, 4 weeks, 8 weeks
Proportion of subject achieving both LDL-C and blood pressure control
Measured: 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 posted30 Aug 2019
- Study start16 Jul 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo-Soo Kim, M.D., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074551
- Sponsor's protocol ID
- HM-AMOS-301
- Status last verified
- Nov 2020
- First submitted
- 29 Aug 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim MC, Ahn Y, Kim MH, Kim SY, Hong TJ, Rhee MY, Kim SH, Hong SJ, Kim H, Kim W, Chae IH, Kang DH, Kim BK, Kim HS. A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia. Am J Cardiovasc Drugs. 2023 Jul;23(4):441-454. doi: 10.1007/s40256-023-00590-9. Epub 2023 Jul 3.
PubMed 37395974
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
- ClinicalTrials.gov ID
- NCT04074551
- Acronym / sponsor ID
- HM-AMOS-301
- Conditions
- Hypertension, Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 30 Aug 2019 (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-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: HCP1701HCP1701 |
| Active Comparator 1 | Active comparator | Drug: Losartan, Drug: AmlodipineHGP0904, HGP0608 |
| Active Comparator 2 | Active comparator | Drug: Losartan, Drug: Rosuvastatin and EzetimibeHGP0608, HCP1306 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 19
- Patients who understood the contents and purpose of this trial and signed informed consent form
- Patients with essential hypertension and dyslipidemia
Key exclusion criteria (20 listed)
- Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
- Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
- Concomitant administration of cyclosporine
- Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
- Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers
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 |
|---|---|---|
| HCP1701HCP1701 | Drug | Experimental |
| LosartanLosartan | Drug | Active Comparator 1, Active Comparator 2 |
| AmlodipineAmlodipine | Drug | Active Comparator 1 |
| Rosuvastatin and EzetimibeRosuvastatin and Ezetimibe | Drug | Active Comparator 2 |
Primary outcome
Change from baseline in LDL-C (%)
Time frame: baseline, 8 weeks
Experimental, Active Control 1
Change from baseline in sitting systolic blood pressure
Time frame: baseline, 8 weeks
Experimental, Active Control 2
10 secondary outcomes
Change from baseline in LDL-C (%)
Time frame: baseline, 8 weeks
Change from baseline in sitting systolic blood pressure
Time frame: baseline, 8 weeks
Change from baseline in LDL-C (%)
Time frame: baseline, 4 weeks
Change from baseline in sitting systolic blood pressure
Time frame: baseline, 4 weeks
Change from baseline in TC, HDL-C, TG (%)
Time frame: baseline, 4 weeks, 8 weeks
Change from baseline in sitting distolic blood pressure
Time frame: baseline, 4 weeks, 8 weeks
Proportion of subject achieving LDL-C control
Time frame: baseline, 4 weeks, 8 weeks
Proportion of subjects achieving blood pressure control
Time frame: baseline, 4 weeks, 8 weeks
Proportion of responder for blood pressure
Time frame: baseline, 4 weeks, 8 weeks
Proportion of subject achieving both LDL-C and blood pressure control
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 30 Nov 2020.
- Derived from this study: PubMed 37395974Kim MC, Ahn Y, Kim MH, Kim SY, Hong TJ, Rhee MY, Kim SH, Hong SJ, Kim H, Kim W, Chae IH, Kang DH, Kim BK, Kim HS. A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia. Am J Cardiovasc Drugs. 2023 Jul;23(4):441-454. doi: 10.1007/s40256-023-00590-9. Epub 2023 Jul 3.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
RecruitingPhase 4
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Hypertension, Hypercortisolemia
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingPhase 2
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Pulmonary Arterial Hypertension
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.
Hyo-Soo Kim, M.D., Ph.D principal investigator
Seoul National University 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 HCP1701, Losartan and Amlodipine in people with Hypertension and Dyslipidemias, 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 3 inclusion and 20 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 Nov 2020. 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 LDL-C (%) (time frame: baseline, 8 weeks). The study lists 2 primary outcomes in all. 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 NCT04074551, 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 30 Nov 2020.