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

NCT03464682 | Unknown Phase 3

• 1 other identifier: HS-25-C-01
• Study Type: interventional
• Target: 720
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent change of LDL-C

  Percent change in LDL-C from baseline to week 12 for each group

  12 weeks

Secondary Outcomes (4)

• Percent change of LDL-C

  52 weeks ( including 2, 4, 8, 18, 24, 38, 52 weeks)

• Percent change of Non-HDL-C

  52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)

• Percent change of HDL-C

  52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)

• Percent change of TC, TG, Apo B, Apo Al

  52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)

Study Arms (6)

HS-25 10mg

EXPERIMENTAL

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

HS-25 20mg

EXPERIMENTAL

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

HS-25 10mg combination with Atorvastatin

EXPERIMENTAL

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

HS-25 20mg combination with Atorvastatin

EXPERIMENTAL

HS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks

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

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

Drug: Placebe of HS-25 and Atorvastatin

Interventions

HS-25 10mg DRUG

HS-25 10mg 1tablet add placebo of HS-25 1 tablet, placebo of Atorvastatin 1 tablet

HS-25 10mg

HS-25 10mg combination with Atorvastatin DRUG

HS-25 10mg 1 tablet , Atorvastatin 10mg 1 tablet, Placebo of HS-25 1 tablet

HS-25 10mg combination with Atorvastatin

HS-25 20mg combination with Atorvastatin DRUG

HS-25 10mg 2 tablets, Atorvastatin 10mg 1 tablet

HS-25 20mg combination with Atorvastatin

Atorvastatin 10mg DRUG

Atorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets

Aorvastatin 10mg; HS-25 10mg combination with Atorvastatin; HS-25 20mg combination with Atorvastatin

HS-25 20mg DRUG

HS-25 10mg 2 tablets, placebo of Atorvastatin 1 tablet

HS-25 20mg

Placebe of HS-25 and Atorvastatin DRUG

Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets

Aorvastatin 10mg; HS-25 10mg; HS-25 10mg combination with Atorvastatin; HS-25 20mg; Placebo of HS-25 and Aorvastatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Hisun Pharmaceutical Co. Ltd.: lead

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Jianan Wang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: March 14, 2018
• Study Start: February 28, 2015
• Primary Completion: December 28, 2018
• Study Completion: May 28, 2019
• Last Updated: October 18, 2018

Record last verified: 2018-02