Status unknownNCT03464682HS-25-C-01Updated Oct 18, 2018

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

A Phase 3 interventional study of HS-25 10mg and HS-25 10mg combination with Atorvastatin in Primary Hypercholesterolemia, sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd.. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-18.

Sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 720
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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 Atorvastatin (10mg)in subjects with LDL-C after a 40-week period of treament.

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 studied

Primary Hypercholesterolemia

Browse trials for

Hypercholesterolemia 1,238

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 720 participants (estimated)

Study arms

Experimental
HS-25 10mg
HS-25 10mg, Placebo of HS-25 1 tablet, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks
Drug: HS-25 10mg · Drug: Placebe of HS-25 and Atorvastatin
Experimental
HS-25 20mg
HS-25 10mg 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks
Drug: HS-25 20mg · Drug: Placebe of HS-25 and Atorvastatin
Experimental
HS-25 10mg combination with Atorvastatin
HS-25 10mg, Aorvastatin 10mg, Placebo of HS-25 1 tablet, oral once daily, 12 weeks
Drug: HS-25 10mg combination with Atorvastatin · Drug: Atorvastatin 10mg · Drug: Placebe of HS-25 and Atorvastatin
Experimental
HS-25 20mg combination with Atorvastatin
HS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks
Drug: HS-25 20mg combination with Atorvastatin · Drug: Atorvastatin 10mg
Active comparator
Aorvastatin 10mg
Aorvastatin 10mg, Placebo of HS-25 2 tablets, oral once daily, 12 weeks
Drug: Atorvastatin 10mg · Drug: Placebe of HS-25 and Atorvastatin
Placebo comparator
Placebo of HS-25 and Aorvastatin
Placebo of HS-25 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12 weeks
Drug: Placebe of HS-25 and Atorvastatin

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

Percent change of LDL-C
Percent change in LDL-C from baseline to week 2, 4, 8, 18, 24, 38, 52 for each group
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)

Study locations

No study locations are listed for this record.

Registry details

Key details

Study ID: NCT03464682
Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Responsible party: Sponsor
First posted: Mar 14, 2018
Start date: Feb 28, 2015
Primary completion: Dec 28, 2018 (estimated)
Completion: May 28, 2019 (estimated)
Last update: Oct 18, 2018

Study contacts

Jianan Wang

principal investigator · Second Affiliated Hospital, School of Medicine, Zhejiang University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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