Trials Sponsors Conditions Drugs Pricing

Conditions

Metabolism Disorder, Lipid Metabolism Disorder, Glucose

Keywords

DyslipidemiaPrediabetes

Outcome Measures

Primary Outcomes (1)

HbA1c levels
To determine whether XZK 1200mg/d, compared to atorvastatin 20mg/d, has a favorable impact on HbA1c levels from baseline to 24 weeks in dyslipidemia patients with prediabetes.
24 weeks

Secondary Outcomes (11)

Fasting blood glucose(FBG),
24 weeks
Post prandial glucose(PPG) 2h
24 weeks
HOMA-IR
24 weeks
LDL-C levels
24 weeks
non HDL-C levels
24 weeks
+6 more secondary outcomes

Study Arms (2)

Xuezhikang Capsule

EXPERIMENTAL

Experimental drug: Xuezhikang Capsule, specification: 300mg / capsule.

Drug: Xuezhikang Capsule

Atorvastatin Calcium Tablets

ACTIVE COMPARATOR

Control drug: Atorvastatin Calcium Tablets, specification: 20mg / tablet.

Drug: Atorvastatin Calcium Tablets

Interventions

Xuezhikang CapsuleDrug

Xuezhikang Capsule, 1200mg / day, twice a day, 2 capsules each time, after meals in the morning and evening.

Xuezhikang Capsule

Atorvastatin Calcium TabletsDrug

Atorvastatin Calcium Tablets, 20mg/day, once a day, one tablet each time, before bedtime;

Atorvastatin Calcium Tablets

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\. Written informed consent provided
\. Age ≥40 years

Sponsors & Collaborators

AstraZeneca
Industrycollaborator
Heart Health Research Center
Otherlead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

MeSH Terms

Conditions

Lipid Metabolism DisordersGlucose Metabolism DisordersDyslipidemiasPrediabetic State

Interventions

xuezhikangAtorvastatin

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

Changsheng Ma, MD
Beijing Anzhen Hospital
PRINCIPAL INVESTIGATOR

Enrollment

392 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 14, 2022

First Posted

February 14, 2022

Study Start

You may not qualify if:

\. Patient with proven or documented atherosclerotic cardiovascular disease (ASCVD), including acute coronary syndrome (ACS), history of myocardial infarction (MI), stable or unstable angina pectoris, coronary or other revascularization, ischemic stroke, transient ischemic attack and peripheral vascular disease (PAD), etc.
Diagnosed diabetes According to 2021 the American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" FPG≥126mg/dL(7.0mmol/L). A know 2-hPG≥200mg/dL(11.1mmol/L)duringOGTT. A1C≥6.5%(48mmol/mol). In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L).
\. Patientswithanylipidloweringdrugsintheprevious3months,includingbut not limited to statins, bile acid sequestrants, cholesterol absorption inhibitors, PCSK9 inhibitors, nicotinic acid, fibric acid derivatives, fibrates, other traditional Chinese medicine and n-3 fatty acids.
Patientswithanyantidiabeticdrugs.
ContraindicationstoXZKorAtorvastatin: Allergic to XZK or Atorvastatin. Pregnancy or breastfeeding
Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg and/ or diastolic blood pressure ≥110 mm Hg) at screening.
Active liver disease or hepatic dysfunction, including continuously elevated liver transaminase due to unknown causes. Abnormal liver function test at baseline (ALT or AST \>3×ULN).
\. Knownrenaldysfunctionorelevatedserumcreatininelevelsatbaseline(with an eGFR≤60 mL/min/1.73 m2).
Otherendocrinediseasesthatmightinfluencethelevelsoflipidorlipoprotein, such as hypothyroidism.
Patient has participated in clinical trials of other drugs in the past three months.
Previous statin treatment causes creatine kinase (CK) increased 10 times, or myalgia myopathy (muscle pain or muscle weakness, accompanied by Creatine phosphokinase (CK) exceeds 10 times the ULN)
Estimated life expectancy \< 6 months at the time of enrollment
Abuse of alcohol, or history of alcohol abuse.
Close affiliation with the investigators, e.g., a close relative for the investigator, dependent person (e.g., employee or student of the investigators)

Compare the Impact of Xuezhikang and Atorvastatin on Glucose Metabolism in Dyslipidemia Patients With Prediabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Xuezhikang Capsule

Atorvastatin Calcium Tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Xuezhikang Capsule

Atorvastatin Calcium Tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations