Hypertension and HyperlipidemiaPhase 3NCT03103256
Clinical Trial to Evaluate the Efficacy and Safety of YHP1701
A Phase 3 study testing YHP1701, YHR1703 and YHR1704 in people with Hypertension and Hyperlipidemia, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to determine superiority of YHP1701 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension and Hyperlipidemia
- What is being tested?
- YHP1701, YHR1703 and YHR1704
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 May 2017to 30 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both man and woman who is over 19 years old
- Patient with dyslipidemia and hypertension
Who cannot join
- sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
- A history of cardiovascular disease
- Rhabdomyolysis, myopathy
- Hypertension or hypercholesterolemia due to secondary causes
- Uncontrolled diabetes
- Evidence of hepatic or renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP1701 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension
The purpose of this study is to determine superiority of YHP1701 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.
- Conditions
- Hypertension and Hyperlipidemia
- Being tested
- YHP1701, YHR1703, YHR1704
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP1701Drug
PO, Once daily (QD), 8 weeks
YHR1703Drug
PO, Once daily (QD), 8 weeks
YHR1704Drug
PO, Once daily (QD), 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| YHP1701 | Experimental | PO, Once daily (QD), 8 weeks Receives: Drug: YHP1701 |
| YHR1703 | Active comparator | PO, Once daily (QD), 8 weeks Receives: Drug: YHR1703 |
| YHR1704 | Active comparator | PO, Once daily (QD), 8 weeks Receives: Drug: YHR1704 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of LDL-Cholesterol
LDL-Cholesterol
Measured: 0, 8 weeks
Change of mean seated Systolic Blood Pressure
Blood Pressure
Measured: 0, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start17 May 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
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 Hypertension and HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Yuhan 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Lee, Study director, Yuhan Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103256
- Sponsor's protocol ID
- YHP1701-301
- Status last verified
- Sep 2018
- First submitted
- 22 Mar 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim W, Chang K, Cho EJ, Ahn JC, Yu CW, Cho KI, Kim YJ, Kang DH, Kim SY, Lee SH, Kim U, Kim SJ, Ahn YK, Lee CH, Shin JH, Kim M, Park CG. A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension. J Clin Hypertens (Greenwich). 2020 Feb;22(2):261-269. doi: 10.1111/jch.13774. Epub 2020 Jan 31.
PubMed 32003938
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP1701 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension
- ClinicalTrials.gov ID
- NCT03103256
- Acronym / sponsor ID
- YHP1701-301
- Conditions
- Hypertension and Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 6 Apr 2017 (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.
The purpose of this study is to determine superiority of YHP1701 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YHP1701 | Experimental | Drug: YHP1701PO, Once daily (QD), 8 weeks |
| YHR1703 | Active comparator | Drug: YHR1703PO, Once daily (QD), 8 weeks |
| YHR1704 | Active comparator | Drug: YHR1704PO, Once daily (QD), 8 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both man and woman who is over 19 years old
- Patient with dyslipidemia and hypertension
Key exclusion criteria (6 listed)
- sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
- A history of cardiovascular disease
- Rhabdomyolysis, myopathy
- Hypertension or hypercholesterolemia due to secondary causes
- Uncontrolled diabetes
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 |
|---|---|---|
| YHP1701PO, Once daily (QD), 8 weeks | Drug | YHP1701 |
| YHR1703PO, Once daily (QD), 8 weeks | Drug | YHR1703 |
| YHR1704PO, Once daily (QD), 8 weeks | Drug | YHR1704 |
Primary outcome
Percent change of LDL-Cholesterol
Time frame: 0, 8 weeks
LDL-Cholesterol
Change of mean seated Systolic Blood Pressure
Time frame: 0, 8 weeks
Blood Pressure
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 7 Sep 2018.
- Derived from this study: PubMed 32003938Kim W, Chang K, Cho EJ, Ahn JC, Yu CW, Cho KI, Kim YJ, Kang DH, Kim SY, Lee SH, Kim U, Kim SJ, Ahn YK, Lee CH, Shin JH, Kim M, Park CG. A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension. J Clin Hypertens (Greenwich). 2020 Feb;22(2):261-269. doi: 10.1111/jch.13774. Epub 2020 Jan 31.
- 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.
Andrew Lee study director
Yuhan Corporation
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 YHP1701, YHR1703 and YHR1704 in people with Hypertension and Hyperlipidemia, run by Yuhan 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 2 inclusion and 6 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 7 Sep 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?
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?
Percent change of LDL-Cholesterol (time frame: 0, 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 NCT03103256, 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 7 Sep 2018.