Primary HypercholesterolemiaPhase 3HS-25-C-01NCT03464682

Efficacy and Safety of HS-25 or in Combination With Atorvastatin in Chinese Adults With Primary Hypercholesterolemia

A Phase 3 study testing HS-25 10mg, HS-25 10mg combination with Atorvastatin and HS-25 20mg combination with Atorvastatin in people with Primary Hypercholesterolemia, run by Zhejiang Hisun Pharmaceutical Co. Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To determine the efficacy of the HS-25 (10mg or 20mg) or in combination with Atorvastatin (10mg)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 (10mg or 20mg) or in combination with… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Primary Hypercholesterolemia
What is being tested?: HS-25 10mg, HS-25 10mg combination with Atorvastatin and HS-25 20mg combination with Atorvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 720 participants
Where: No sites listed yet
Study dates: 28 Feb 2015to 28 May 2019
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who are 18 to 70 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 3.36mmol/L (130 mg/dL) to 4.88 mmol/L (189 mg/dL) (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment (statins) for at least 6 weeks before signed written informed consent;
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 3.36mmol/L (130 mg/dL) to 4.88 mmol/L (189 mg/dL) (inclusive) for inclusion in the study.

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 - history of Severe Endiocrine disease (for example Thyroid function abnormal) - History of a positive test for human immunodeficiency virus, hepatitis B or hepatitis C.

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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, Double Dummy,Placebo Controlled, Efficacy and Safety Study of HS-25 in Combination With Atovastatin in Adults With Primary Hypercholesterolemia

Read the detailed description

This is a 12-week, randomized, double-blind, double dummy, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor HS-25 (10mg or 20mg) or in combination with Atorvastatin (10mg) 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 18-70 years old men or women who are using a highly effective birth control method or are not of childbearing potential;subjects with not treated by statins in six months before signature of the informed consent.Subjects with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease or treated are not eligible for participation in the study.

Conditions: Primary Hypercholesterolemia
Being tested: HS-25 10mg, HS-25 10mg combination with Atorvastatin, HS-25 20mg combination with Atorvastatin, Atorvastatin 10mg, HS-25 20mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HS-25 10mgDrug
HS-25 10mg 1tablet add placebo of HS-25 1 tablet, placebo of Atorvastatin 1 tablet
HS-25 10mg combination with AtorvastatinDrug
HS-25 10mg 1 tablet , Atorvastatin 10mg 1 tablet, Placebo of HS-25 1 tablet
HS-25 20mg combination with AtorvastatinDrug
HS-25 10mg 2 tablets, Atorvastatin 10mg 1 tablet
Atorvastatin 10mgDrug
Atorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets
HS-25 20mgDrug
HS-25 10mg 2 tablets, placebo of Atorvastatin 1 tablet
Placebe of HS-25 and AtorvastatinDrug
Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets

Study groups in NCT03464682
Study group	Role	What they receive
HS-25 10mg	Experimental	HS-25 10mg, Placebo of HS-25 1 tablet, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks Receives: Drug: HS-25 10mg; Drug: Placebe of HS-25 and Atorvastatin
HS-25 20mg	Experimental	HS-25 10mg 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks Receives: Drug: HS-25 20mg; Drug: Placebe of HS-25 and Atorvastatin
HS-25 10mg combination with Atorvastatin	Experimental	HS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks Receives: Drug: HS-25 10mg combination with Atorvastatin; Drug: Atorvastatin 10mg; Drug: Placebe of HS-25 and Atorvastatin
HS-25 20mg combination with Atorvastatin	Experimental	HS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks Receives: Drug: HS-25 20mg combination with Atorvastatin; Drug: Atorvastatin 10mg
Aorvastatin 10mg	Active comparator	Aorvastatin 10mg, Placebo of HS-25 2 tablets, oral once daily, 12 weeks Receives: Drug: Atorvastatin 10mg; Drug: Placebe of HS-25 and Atorvastatin
Placebo of HS-25 and Aorvastatin	Placebo comparator	Placebo of HS-25 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12 weeks Receives: Drug: Placebe of HS-25 and Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent change of LDL-C
Percent change in LDL-C from baseline to week 12 for each group
Measured: 12 weeks

Secondary outcomes (4)

Percent change of LDL-C
Percent change in LDL-C from baseline to week 2, 4, 8, 18, 24, 38, 52 for each group
Measured: 52 weeks ( including 2, 4, 8, 18, 24, 38, 52 weeks)
Percent change of Non-HDL-C
Percent change in Non-HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group
Measured: 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)
Percent change of HDL-C
Percent change in HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group
Measured: 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)
Percent change of TC, TG, Apo B, Apo Al
Percent change in TC, TG, Apo B, Apo Al from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group
Measured: 52 weeks ( including 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.

28 Feb 201528 May 2019

First posted14 Mar 2018
Study start28 Feb 2015
Primary completion28 Dec 2018 (estimated)
Study completion28 May 2019 (estimated)

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 720 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03464682
Sponsor's protocol ID: HS-25-C-01
Acronym: HS-25-C-01
Status last verified: Feb 2018
First submitted: 7 Feb 2018
Last updated: 18 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

All Primary Hypercholesterolemia trials

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, Double Dummy,Placebo Controlled, Efficacy and Safety Study of HS-25 in Combination With Atovastatin in Adults With Primary Hypercholesterolemia
ClinicalTrials.gov ID: NCT03464682
Acronym / sponsor ID: HS-25-C-01 / HS-25-C-01
Conditions: Primary Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 720 participants (estimated)
Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
Study start: 28 Feb 2015 (actual)
Primary completion: 28 Dec 2018 (estimated)
Study completion: 28 May 2019 (estimated)
First posted: 14 Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
HS-25 10mg	Experimental	Drug: HS-25 10mg, Drug: Placebe of HS-25 and AtorvastatinHS-25 10mg, Placebo of HS-25 1 tablet, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks
HS-25 20mg	Experimental	Drug: HS-25 20mg, Drug: Placebe of HS-25 and AtorvastatinHS-25 10mg 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks
HS-25 10mg combination with Atorvastatin	Experimental	Drug: HS-25 10mg combination with Atorvastatin, Drug: Atorvastatin 10mg, Drug: Placebe of HS-25 and AtorvastatinHS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks
HS-25 20mg combination with Atorvastatin	Experimental	Drug: HS-25 20mg combination with Atorvastatin, Drug: Atorvastatin 10mgHS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks
Aorvastatin 10mg	Active comparator	Drug: Atorvastatin 10mg, Drug: Placebe of HS-25 and AtorvastatinAorvastatin 10mg, Placebo of HS-25 2 tablets, oral once daily, 12 weeks
Placebo of HS-25 and Aorvastatin	Placebo comparator	Drug: Placebe of HS-25 and AtorvastatinPlacebo of HS-25 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects who are 18 to 70 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 3.36mmol/L (130 mg/dL) to 4.88 mmol/L (189 mg/dL) (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment (statins) for at least 6 weeks before signed written informed consent;
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 3.36mmol/L (130 mg/dL) to 4.88 mmol/L (189 mg/dL) (inclusive) for inclusion in the study.

Key exclusion criteria (12 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-25 10mgHS-25 10mg 1tablet add placebo of HS-25 1 tablet, placebo of Atorvastatin 1 tablet	Drug	HS-25 10mg
HS-25 10mg combination with AtorvastatinHS-25 10mg 1 tablet , Atorvastatin 10mg 1 tablet, Placebo of HS-25 1 tablet	Drug	HS-25 10mg combination with Atorvastatin
HS-25 20mg combination with AtorvastatinHS-25 10mg 2 tablets, Atorvastatin 10mg 1 tablet	Drug	HS-25 20mg combination with Atorvastatin
Atorvastatin 10mgAtorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets	Drug	Aorvastatin 10mg, HS-25 10mg combination with Atorvastatin, HS-25 20mg combination with Atorvastatin
HS-25 20mgHS-25 10mg 2 tablets, placebo of Atorvastatin 1 tablet	Drug	HS-25 20mg
Placebe of HS-25 and AtorvastatinPlacebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets	Drug	Aorvastatin 10mg, HS-25 10mg, HS-25 10mg combination with Atorvastatin, HS-25 20mg, Placebo of HS-25 and Aorvastatin

Primary outcome

Percent change of LDL-C
Time frame: 12 weeks
Percent change in LDL-C from baseline to week 12 for each group

4 secondary outcomes

Percent change of LDL-C
Time frame: 52 weeks ( including 2, 4, 8, 18, 24, 38, 52 weeks)
Percent change of Non-HDL-C
Time frame: 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)
Percent change of HDL-C
Time frame: 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)
Percent change of TC, TG, Apo B, Apo Al
Time frame: 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.

Related trials for Primary Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

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.

Jianan Wang principal investigator

Second Affiliated Hospital, Zhejiang University, School of Medicine

Questions about this trial

What is this clinical trial studying?

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 12 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 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?

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?

Percent change of LDL-C (time frame: 12 weeks). 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 NCT03464682.

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.