HypertensionPhase 3NCT03639480
Study to Evaluate the Safety and Efficacy of CJ-30061 in Hypertensive Patients With Hyperlipidemia
A Phase 3 study testing Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg, Amlodipine 10mg+Valsartan 160mg and Valsartan 160mg+Atorvastatin 40mg in people with Hypertension and Hyperlipidemia, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
To evaluate the safety and efficacy of CJ-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin combination therapy in hypertensive patients with hyperlipidemia Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg, Amlodipine 10mg+Valsartan 160mg and Valsartan 160mg+Atorvastatin 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2017to Oct 2018
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 19 and 74 years
- Diagnosed with essintial hypertension(average siSBP ≥ 140mmHg) accompanying hyperlipidemia(LDL-C ≥ 100mg/dL) and were on or off treatment at Visit 1(screening)
- Decided to participate in the study and provided signed informed consent form voluntarily after receiving explanation of the objectives, methods, and effects of the study
Who cannot join
- Severe hypertension defined as average siDBP ≥ 120mmHg or average siSBP ≥ 200mmHg at Visit 1(screening)
- The difference in BPs between those measured at the reference arm at Visit 1(screening) was ≥ 10mmHg for siDBP or ≥ 20mmHg for siSBP
- LDL-C > 250mg/dL or TG ≥ 400mg/dL at Visit 1(screening)
- Secondary hypertension
- Diagnosis of type 1 diabetes mellitus(DM) or uncontrolled DM(patients on insulin therapy or patients with HbA1c ≥ 9%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Multi-center Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of CJ-30061 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Atorvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
To evaluate the safety and efficacy of CJ-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin combination therapy in hypertensive patients with hyperlipidemia
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg, Amlodipine 10mg+Valsartan 160mg, Valsartan 160mg+Atorvastatin 40mg
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mgDrug
Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
Amlodipine 10mg+Valsartan 160mgDrug
Amlodipine 10mg+Valsartan 160mg
Valsartan 160mg+Atorvastatin 40mgDrug
Valsartan 160mg+Atorvastatin 40mg
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg Receives: Drug: Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg |
| Reference 1 | Active comparator | Amlodipine 10mg+Valsartan 160mg Receives: Drug: Amlodipine 10mg+Valsartan 160mg |
| Reference 2 | Active comparator | Valsartan 160mg+Atorvastatin 40mg Receives: Drug: Valsartan 160mg+Atorvastatin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in siSBP
Change in siSBP from baseline after 8 weeks of study treatment
Measured: baseline and 8 weeks
Change in LDL-C
Change in LDL-C from baseline after 8 weeks of study treatment
Measured: baseline 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 posted21 Aug 2018
- Study start13 Oct 2017
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
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 HK inno.N CorporationThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Duk-Hyun Kang, Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639480
- Sponsor's protocol ID
- CJ_EXA_301
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multi-center Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of CJ-30061 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Atorvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT03639480
- Acronym / sponsor ID
- CJ_EXA_301
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 21 Aug 2018 (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.
To evaluate the safety and efficacy of CJ-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin combination therapy in hypertensive patients with hyperlipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mgAmlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg |
| Reference 1 | Active comparator | Drug: Amlodipine 10mg+Valsartan 160mgAmlodipine 10mg+Valsartan 160mg |
| Reference 2 | Active comparator | Drug: Valsartan 160mg+Atorvastatin 40mgValsartan 160mg+Atorvastatin 40mg |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 19 and 74 years
- Diagnosed with essintial hypertension(average siSBP ≥ 140mmHg) accompanying hyperlipidemia(LDL-C ≥ 100mg/dL) and were on or off treatment at Visit 1(screening)
- Decided to participate in the study and provided signed informed consent form voluntarily after receiving explanation of the objectives, methods, and effects of the study
Key exclusion criteria (5 listed)
- Severe hypertension defined as average siDBP ≥ 120mmHg or average siSBP ≥ 200mmHg at Visit 1(screening)
- The difference in BPs between those measured at the reference arm at Visit 1(screening) was ≥ 10mmHg for siDBP or ≥ 20mmHg for siSBP
- LDL-C > 250mg/dL or TG ≥ 400mg/dL at Visit 1(screening)
- Secondary hypertension
- Diagnosis of type 1 diabetes mellitus(DM) or uncontrolled DM(patients on insulin therapy or patients with HbA1c ≥ 9%)
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 |
|---|---|---|
| Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mgAmlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg | Drug | Test |
| Amlodipine 10mg+Valsartan 160mgAmlodipine 10mg+Valsartan 160mg | Drug | Reference 1 |
| Valsartan 160mg+Atorvastatin 40mgValsartan 160mg+Atorvastatin 40mg | Drug | Reference 2 |
Primary outcome
Change in siSBP
Time frame: baseline and 8 weeks
Change in siSBP from baseline after 8 weeks of study treatment
Change in LDL-C
Time frame: baseline and 8 weeks
Change in LDL-C from baseline after 8 weeks of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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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.
Duk-Hyun Kang, Ph.D principal investigator
Asan Medical Center
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 Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg, Amlodipine 10mg+Valsartan 160mg and Valsartan 160mg+Atorvastatin 40mg in people with Hypertension and Hyperlipidemia, run by HK inno.N Corporation 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 5 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 21 Aug 2018. 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?
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 in siSBP (time frame: baseline and 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?
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 Aug 2018.