Primary HypercholesterolemiaPhase 3HS-25-III-01NCT03413462
Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia
A Phase 3 study testing HS-25 in people with Primary Hypercholesterolemia, run by Zhejiang Hisun Pharmaceutical Co. Ltd..
Trial summary
To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in adults with primary hypercholesterolemia; To determine the safety of HS-25 (20mg) in subjects with LDL-C Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- HS-25
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 374 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2016to 20 Sep 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are 18 to 75 years of age, male or female using a highly effective birth control method or not of child-bearing potential, at Visit 1 (screening visit).
- LDL-C 130 to 189 mg/dL (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks.
- A qualifying LDL-C value must be obtained at the beginning and end of the placebo run-in (Visit 2 and Visit 3) and the Visit 3 value must be within 12% of the value at Visit 2, higher or lower; the average of both qualifying values must be in the range of 130 to 189 mg/dL (inclusive) for inclusion in the study.
- TG ≤ 350 mg/dL on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks and TG levels must be ≤ 350 mg/dL at both Visit 2 and Visit 3
- Signed written informed consent.
Who cannot join
- Liver transaminases > 1.5 x upper limit of normal.
- Homozygous Familial Hypercholesterolemia.
- Subject who was diagnosed as diabetes with aged greater than 40 years old.
- Subject who was diagnosed as diabetes with one of the following of cardiovascular risk factorss: Hypertention Bp ≥ 140/90mmHg,or smoking, or low HDL-C (1.04mmol/L), or BMI≥28kg/m2.
- Women who are pregnant or breast feeding.
- Atherosclerotic cardiovascular disease including Arteriosclerotic heart disease, Acute coronary syndrome，Coronary artery bypass graft,Coronary angioplastyPeripheral arteriosclerosis,Cerebrovascular accident
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- history of Severe Endiocrine disease (for example Thyroid function abnormal)
- History of a positive test for human immunodeficiency virus, hepatitis B or hepatitis C.
- History of advanced cancer
- Arrhythmias need to be treated by medications
- Had severe injured or surgery in 6 months before study start.
- Hypersensitive to HS-25 or place.
- History of intolerance to ezetimibe.
- Participation other studies in three months.
- Treatment with a fibric acid derivative (eg, fenofibrate, gemfibrozil), probucol, warfarin, systemic corticosteroid, cyclosporine or other immunosuppressant agent within the prior 12 weeks.
About this study
Official title: Multi-center,Randomized,Double Blind,Placebo Controlled,Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia
To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in adults with primary hypercholesterolemia;
To determine the safety of HS-25 (20mg) in subjects with LDL-C
Read the detailed description
This is a 12-week, randomized, double-blind, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor HS-25 on LDL-C levels in adults who have untreated LDL-C levels ranging from 3.36-4.88mmol/L(130-189 mg/dL)and fasting triglyceride levels < 350 mg/dL. Eligibility is restricted to 18-75 years old men or women who are using a highly effective birth control method or are not of childbearing potential. Patients with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease are not eligible for participation in the study.
- Conditions
- Primary Hypercholesterolemia
- Being tested
- HS-25, Placebo of HS-25
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-25Drug
HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.
Placebo of HS-25Drug
Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HS-25 | Active comparator | 20mg, QD, 12 weeks Receives: Drug: HS-25 |
| Placebo of HS-25 | Placebo comparator | 20mg, QD, 12 weeks Receives: Drug: HS-25; Drug: Placebo of HS-25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Measured: 2,4,8,12,18,24,38,52 weeks
Secondary outcomes (4)
Non-HDL-C
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Measured: 2,4,8,12,18,24,38,52 weeks
HDL-C
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Measured: 2,4,8,12,18,24,38,52 weeks
TC
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Measured: 2,4,8,12,18,24,38,52 weeks
TG
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Measured: 2,4,8,12,18,24,38,52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start12 Apr 2016
- Primary completion20 Apr 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Huo, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413462
- Sponsor's protocol ID
- HS-25-III-01
- Acronym
- HS-25-III-01
- Status last verified
- Jan 2018
- First submitted
- 22 Jan 2018
- Last updated
- 18 Oct 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 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center,Randomized,Double Blind,Placebo Controlled,Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03413462
- Acronym / sponsor ID
- HS-25-III-01 / HS-25-III-01
- Conditions
- Primary Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 29 Jan 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 determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in adults with primary hypercholesterolemia;
To determine the safety of HS-25 (20mg) in subjects with LDL-C
Detailed description
This is a 12-week, randomized, double-blind, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor HS-25 on LDL-C levels in adults who have untreated LDL-C levels ranging from 3.36-4.88mmol/L(130-189 mg/dL)and fasting triglyceride levels < 350 mg/dL. Eligibility is restricted to 18-75 years old men or women who are using a highly effective birth control method or are not of childbearing potential. Patients with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease are not eligible for participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-25 | Active comparator | Drug: HS-2520mg, QD, 12 weeks |
| Placebo of HS-25 | Placebo comparator | Drug: HS-25, Drug: Placebo of HS-2520mg, QD, 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are 18 to 75 years of age, male or female using a highly effective birth control method or not of child-bearing potential, at Visit 1 (screening visit).
- LDL-C 130 to 189 mg/dL (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks.
- A qualifying LDL-C value must be obtained at the beginning and end of the placebo run-in (Visit 2 and Visit 3) and the Visit 3 value must be within 12% of the value at Visit 2, higher or lower; the average of both qualifying values must be in the range of 130 to 189 mg/dL (inclusive) for inclusion in the study.
- TG ≤ 350 mg/dL on a cholesterol lowering diet but no lipid modifying drug treatment for at least 6 weeks and TG levels must be ≤ 350 mg/dL at both Visit 2 and Visit 3
- Signed written informed consent.
Key exclusion criteria (15 listed)
- Liver transaminases > 1.5 x upper limit of normal.
- Homozygous Familial Hypercholesterolemia.
- Subject who was diagnosed as diabetes with aged greater than 40 years old.
- Subject who was diagnosed as diabetes with one of the following of cardiovascular risk factorss: Hypertention Bp ≥ 140/90mmHg,or smoking, or low HDL-C (1.04mmol/L), or BMI≥28kg/m2.
- Women who are pregnant or breast feeding.
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 |
|---|---|---|
| HS-25HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks. | Drug | HS-25, Placebo of HS-25 |
| Placebo of HS-25Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks. | Drug | Placebo of HS-25 |
Primary outcome
LDL-C
Time frame: 2,4,8,12,18,24,38,52 weeks
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
4 secondary outcomes
Non-HDL-C
Time frame: 2,4,8,12,18,24,38,52 weeks
HDL-C
Time frame: 2,4,8,12,18,24,38,52 weeks
TC
Time frame: 2,4,8,12,18,24,38,52 weeks
TG
Time frame: 2,4,8,12,18,24,38,52 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 18 Oct 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.
Yong Huo principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-25 in people with Primary Hypercholesterolemia, run by Zhejiang Hisun Pharmaceutical Co. Ltd..
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 5 inclusion and 15 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 18 Oct 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. Some participants in this study may receive a placebo. 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?
LDL-C (time frame: 2,4,8,12,18,24,38,52 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 18 Oct 2018.