HS-25-C-01: Efficacy and Safety of HS-25 or in Combination With Atorvastatin in Chinese Adults With Primary Hypercholesterolemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
HS-25 10mg 1tablet add placebo of HS-25 1 tablet, placebo of Atorvastatin 1 tablet
Drug: Placebe of HS-25 and Atorvastatin
Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets
|
| Experimental: HS-25 20mg HS-25 10mg 2 tablets, Placebo of Aorvastatin 1 tablet, oral once daily, 12weeks |
Drug: HS-25 20mg
HS-25 10mg 2 tablets, placebo of Atorvastatin 1 tablet
Drug: Placebe of HS-25 and Atorvastatin
Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets
|
| 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
HS-25 10mg 1 tablet , Atorvastatin 10mg 1 tablet, Placebo of HS-25 1 tablet
Drug: Atorvastatin 10mg
Atorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets
Drug: Placebe of HS-25 and Atorvastatin
Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets
|
| Experimental: HS-25 20mg combination with Atorvastatin HS-25 20mg, Aorvastatin 10mg, oral once daily, 12 weeks |
Drug: HS-25 20mg combination with Atorvastatin
HS-25 10mg 2 tablets, Atorvastatin 10mg 1 tablet
Drug: Atorvastatin 10mg
Atorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets
|
| Active Comparator: Aorvastatin 10mg Aorvastatin 10mg, Placebo of HS-25 2 tablets, oral once daily, 12 weeks |
Drug: Atorvastatin 10mg
Atorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets
Drug: Placebe of HS-25 and Atorvastatin
Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets
|
| 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
Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets
|
Outcome Measures
Primary Outcome Measures
- Percent change of LDL-C [12 weeks]
Percent change in LDL-C from baseline to week 12 for each group
Secondary Outcome Measures
- Percent change of LDL-C [52 weeks ( including 2, 4, 8, 18, 24, 38, 52 weeks)]
Percent change in LDL-C from baseline to week 2, 4, 8, 18, 24, 38, 52 for each group
- Percent change of Non-HDL-C [52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)]
Percent change in Non-HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group
- Percent change of HDL-C [52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)]
Percent change in HDL-C from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group
- Percent change of TC, TG, Apo B, Apo Al [52 weeks ( including 2, 4, 8, 12, 18, 24, 38, 52 weeks)]
Percent change in TC, TG, Apo B, Apo Al from baseline to week 2, 4, 8, 12, 18, 24, 38, 52 for each group
Eligibility Criteria
Criteria
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:
-
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zhejiang Hisun Pharmaceutical Co. Ltd.
Investigators
- Principal Investigator: Jianan Wang, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS-25-C-01