Back to resultsEfficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia (HS-25-III-01)
Primary Purpose
Primary Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HS-25
Placebo of HS-25
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- 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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
HS-25
Placebo of HS-25
Arm Description
20mg, QD, 12 weeks
20mg, QD, 12 weeks
Outcomes
Primary Outcome Measures
LDL-C
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Secondary Outcome Measures
Non-HDL-C
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
HDL-C
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
TC
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
TG
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Full Information
NCT ID
NCT03413462
First Posted
January 22, 2018
Last Updated
October 17, 2018
Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03413462
Brief Title
Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia
Acronym
HS-25-III-01
Official Title
Multi-center,Randomized,Double Blind,Placebo Controlled,Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 12, 2016 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
374 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HS-25
Arm Type
Active Comparator
Arm Description
20mg, QD, 12 weeks
Arm Title
Placebo of HS-25
Arm Type
Placebo Comparator
Arm Description
20mg, QD, 12 weeks
Intervention Type
Drug
Intervention Name(s)
HS-25
Intervention Description
HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo of HS-25
Intervention Description
Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.
Primary Outcome Measure Information:
Title
LDL-C
Description
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Time Frame
2,4,8,12,18,24,38,52 weeks
Secondary Outcome Measure Information:
Title
Non-HDL-C
Description
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Time Frame
2,4,8,12,18,24,38,52 weeks
Title
HDL-C
Description
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Time Frame
2,4,8,12,18,24,38,52 weeks
Title
TC
Description
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Time Frame
2,4,8,12,18,24,38,52 weeks
Title
TG
Description
Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment
Time Frame
2,4,8,12,18,24,38,52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Huo
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia
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