Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia

NCT03413462 | Completed Phase 3

• 1 other identifier: HS-25-III-01
• Study Type: interventional
• Target: 374
• Locations: 0 countries
• Sites: N/A

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

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• LDL-C

  Percent change from baseline in LDL-C after 2,4,8,12,18,24,38,52 weeks of double-blind treatment

  2,4,8,12,18,24,38,52 weeks

Secondary Outcomes (4)

• Non-HDL-C

  2,4,8,12,18,24,38,52 weeks

• HDL-C

  2,4,8,12,18,24,38,52 weeks

• TC

  2,4,8,12,18,24,38,52 weeks

• TG

  2,4,8,12,18,24,38,52 weeks

Study Arms (2)

HS-25

ACTIVE COMPARATOR

20mg, QD, 12 weeks

Drug: HS-25

Placebo of HS-25

PLACEBO COMPARATOR

20mg, QD, 12 weeks

Drug: HS-25; Drug: Placebo of HS-25

Interventions

HS-25 DRUG

HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.

HS-25; Placebo of HS-25

Placebo of HS-25 DRUG

Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.

Placebo of HS-25

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

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

Study Officials

• Yong Huo

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: April 12, 2016
• Primary Completion: April 20, 2018
• Study Completion: September 20, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-01