Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases

NCT03433196 | Completed Phase 3

• 1 other identifier: HS-25-III-02
• Study Type: interventional
• Target: 255
• 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 combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases

Conditions

Hypercholesterolemia in Coronaory Heart Disease

Outcome Measures

Primary Outcomes (1)

• Percent change of LDL-C

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

  2,4,8,12 weeks

Secondary Outcomes (2)

• Percent change of Non-HDL-C

  2,4,8,12 weeks

• Percent change of TC,TG,ApoB,ApoAI

  2,4,8,12 weeks

Study Arms (2)

HS-25 and Atorvastatin

EXPERIMENTAL

HS-25 20mg, Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet

Drug: HS-25 and Atorvastatin

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin 20mg, Placebo of HS-25 2 tablets

Drug: Atorvastatin

Interventions

HS-25 and Atorvastatin DRUG

HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily

HS-25 and Atorvastatin

Atorvastatin DRUG

Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily

Atorvastatin

Eligibility Criteria

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

You may qualify if:

• Diet control for 14 weeks, Atorvastatin 10mg once daily for 6 weeks or above;
• The average of both qualifying values must be in the range of 2.07 mmol/L to 3.36 mmol/L. 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;
• Must meet the one of diseases as following:
• Subjects who have stable coronary heart disease;
• Subjects who diagnosed ischemic stroke in stable condition;
• Subjects who diagnosed as Diabetes mellitus

You may not qualify if:

• history of Severe Endiocrine disease (for example Thyroid function abnormal);
• History of advanced cancer
• Arrhythmias need to be treated by medications history of Hemorrhagic stroke;
• Cardiac dysfunction;
• Unstable ASCVD;
• History of organ transplant;
• Hypersensitive to HS-25 or place;
• uncontrolled or new diagnosed diabetes mellitus;
• HCV and HBsAg positive

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

• Litong Qi

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: June 7, 2016
• Primary Completion: June 30, 2018
• Study Completion: October 10, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-02