The Therapeutic Effects of Statins and Berberine on the Hyperlipemia

NCT01697735 | Terminated Phase 4

• 1 other identifier: WZ medical college
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Statins are cholesterol-lowering medications that are often prescribed for patients with high cholesterol and who are at risk for cardiovascular disease (CVD). But there are many patients whose hyperlipemia are not well controlled. If investigators are simply doubling the statins, that only 6% of the benefit can be received. And it often has significant side effects in elder patients. Several studies have suggested that the use of berberine can effectively lower blood lipids. The chemical structure and mechanisms of drug is clearly, and the side effects are seldom, the price of berberine is very cheap. The purpose of this study is to observe the therapeutic effects of combination of statins and berberine on the patients with hyperlipemia whose level of the lipid are not well controlled when only using statins.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Change from baseline in combination statins with berberine on lipid level

  Measured at baseline, weeks 4 and 8

Secondary Outcomes (1)

• Adherence of statins and berberine treatment

  Measured at weeks 4 and 8

Study Arms (2)

Berberine;Atorvastatin or Rosuvastatin

EXPERIMENTAL

Follow the previous administration program，participants will continue to receive 20mg Atorvastatin daily or 10mg Rosuvastatin daily; Besides taking statins, Participants will receive 500mg berberine twice a day for 8 weeks.

Drug: Berberine;Atorvastatin or Rosuvastatin

Atorvastatin or Rosuvastatin

ACTIVE COMPARATOR

Due to the different clinical prescriptions by different doctors and similar Efficacy in lowering lipids.Usually,Participants receive 20mg Atorvastatin daily or 10mg Rosuvastatin to treat hyperlipidemia.

Drug: Atorvastatin or Rosuvastatin

Interventions

Berberine;Atorvastatin or Rosuvastatin DRUG

Participants will receive 500mg Berberine twice a day for 8 weeks; Follow the previous administration program，participants will continue to receive 20mg Atorvastatin daily or 10mg Rosuvastatin daily.

Also known as: Berberine;, Liptor, Crestor

Berberine;Atorvastatin or Rosuvastatin

Atorvastatin or Rosuvastatin DRUG

Due to the different clinical prescriptions by different doctors and similar Efficacy in lowering lipids.Usually,Participants receive 20mg Atorvastatin daily or 10mg Rosuvastatin to treat hyperlipidemia.

Also known as: Liptor, Crestor

Atorvastatin or Rosuvastatin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current use of lipid-lowering medications;
• Documented cardiovascular disease (CVD) by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound), previous myocardial infarction (MI), acute coronary syndrome (ACS), coronary revascularization \[percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)\] and other arterial revascularization procedures, ischaemic stroke, peripheral arterial disease(PAD);
• Patients with type 2 diabetes, patients with type 1 diabetes with target organ damage (such as microalbuminuria); Patients with moderate to severe chronic kidney disease \[glomerular filtration rate (GFR) \< 60 mL/min/1.73㎡\];
• Markedly elevated single risk factors such as familial dyslipidaemias and severe hypertension;
• A calculated SCORE ≥1% for 10 year risk of fatal CVD

You may not qualify if:

• Cancer;
• HIV infected;
• Medical or psychiatric condition that prevents full study participation or follow-up (e.g., active psychosis);
• Active liver disease or unexplained persistent elevated transaminase levels；
• Major surgery or hospitalization in the 3 months prior to study entry;
• Current use of cyclosporin, erythromycin, clarithromycin, nefazodone, or any "azole" antifungals, including fluconazole, itraconazole, ketoconazole, mibefradil, or protease inhibitors;
• Female of childbearing potential;
• Severe gastrointestinal disease;
• With berberine using contraindications;
• Secondary hyperlipidemia
• Current participation in another clinical trial

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Second Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Rosuvastatin Calcium; Berberine; Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Jifei Tang, MD

  Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

CN (1)