HS-25-III-01: Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: HS-25 20mg, QD, 12 weeks |
Drug: HS-25
HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.
|
| Placebo Comparator: Placebo of HS-25 20mg, QD, 12 weeks |
Drug: HS-25
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
Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.
|
Outcome Measures
Primary Outcome Measures
- LDL-C [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
Secondary Outcome Measures
- Non-HDL-C [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
- HDL-C [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
- TC [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
- TG [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
Eligibility Criteria
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.
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Subject who was diagnosed as diabetes with aged greater than 40 years old.
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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.
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Women who are pregnant or breast feeding.
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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
-
History of advanced cancer
-
Arrhythmias need to be treated by medications
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Had severe injured or surgery in 6 months before study start.
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Hypersensitive to HS-25 or place.
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History of intolerance to ezetimibe.
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Participation other studies in three months.
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Treatment with a fibric acid derivative (eg, fenofibrate, gemfibrozil), probucol, warfarin, systemic corticosteroid, cyclosporine or other immunosuppressant agent within the prior 12 weeks.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zhejiang Hisun Pharmaceutical Co. Ltd.
Investigators
- Principal Investigator: Yong Huo, Peking University First Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS-25-III-01