Hypertension With HyperlipidemiaPhase 3NCT03536598
Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia
A Phase 3 study testing Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg, Amlodipine 10 mg + Valsartan 160 mg and Valsartan 160 mg + Rosuvastatin 20 mg in people with Hypertension With Hyperlipidemia, run by HK inno.N Corporation.
Trial summary
To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin 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 With Hyperlipidemia
- What is being tested?
- Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg, Amlodipine 10 mg + Valsartan 160 mg and Valsartan 160 mg + Rosuvastatin 20 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2016to 4 Sep 2017
- 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
- Patient with dyslipidemia and hypertension
Who cannot join
- At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
- At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg
- Secodary hypertension
- Type I or uncontrolled diabetes mellitus (HbA1c ≥ 9 %)
About this study
Official title: A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients with hyperlipidemia
- Conditions
- Hypertension With Hyperlipidemia
- Being tested
- Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg, Amlodipine 10 mg + Valsartan 160 mg, Valsartan 160 mg + Rosuvastatin 20 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mgDrug
Amlodipine 10 mg + Valsartan 160 mgDrug
Valsartan 160 mg + Rosuvastatin 20 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg Receives: Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg |
| Reference 1 | Active comparator | Amlodipine 10mg + Valsartan 160mg Receives: Drug: Amlodipine 10 mg + Valsartan 160 mg |
| Reference 2 | Active comparator | Valsartan 160mg + Rosuvastatin 20mg Receives: Drug: Valsartan 160 mg + Rosuvastatin 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of LDL-C and siSBP
Mean change from baseline in LDL-C and siSBP at Week 8
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 posted24 May 2018
- Study start14 Oct 2016
- Primary completion4 Sep 2017
- Study completion4 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension With HyperlipidemiaStudies 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Ju Choi, Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536598
- Sponsor's protocol ID
- CJ_EXR_301
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 30 May 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 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of CJ-30060 Compared With Amlodipine/Valsartan Combination Therapy and Valsartan/Rosuvastatin Combination Therapy in Hypertensive Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT03536598
- Acronym / sponsor ID
- CJ_EXR_301
- Conditions
- Hypertension With Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 4 Sep 2017 (actual)
- First posted
- 24 May 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-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin 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 10 mg + Valsartan 160 mg + Rosuvastatin 20 mgAmlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg |
| Reference 1 | Active comparator | Drug: Amlodipine 10 mg + Valsartan 160 mgAmlodipine 10mg + Valsartan 160mg |
| Reference 2 | Active comparator | Drug: Valsartan 160 mg + Rosuvastatin 20 mgValsartan 160mg + Rosuvastatin 20mg |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 19 and 74 years
- Patient with dyslipidemia and hypertension
Key exclusion criteria (4 listed)
- At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
- At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg
- Secodary hypertension
- Type I or uncontrolled diabetes mellitus (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 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg | Drug | Test |
| Amlodipine 10 mg + Valsartan 160 mg | Drug | Reference 1 |
| Valsartan 160 mg + Rosuvastatin 20 mg | Drug | Reference 2 |
Primary outcome
Change of LDL-C and siSBP
Time frame: baseline and 8 weeks
Mean change from baseline in LDL-C and siSBP at Week 8
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 May 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.
Dong Ju Choi, Ph.D principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg, Amlodipine 10 mg + Valsartan 160 mg and Valsartan 160 mg + Rosuvastatin 20 mg in people with Hypertension With Hyperlipidemia, run by HK inno.N Corporation.
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 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 of LDL-C and siSBP (time frame: baseline and 8 weeks). 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 30 May 2018.