Comparison of Coenzyme A and Pantethine Capsule for Safety and Efficacy On Patients With Hyperlipidemia

NCT01811082 | Completed Phase 3 DMC

• 1 other identifier: 2010MMXX2CoA006
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A capsule with a marketed drug, Pantethine Capsule, in Chinese patients with moderate dyslipidemia.

Conditions

Hyperlipoproteinemia

Outcome Measures

Primary Outcomes (1)

• serum triglyceride level

  The primary efficacy variable was the percentage change in serum lipid level from baseline to 4 and 8 weeks of treatment.

  10 months

Secondary Outcomes (1)

• serum total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol levels

  10 months

Study Arms (2)

Coenzyme A 400mg

EXPERIMENTAL

Coenzyme A 400mg per day

Drug: Coenzyme A

Pantethine 600mg

ACTIVE COMPARATOR

Pantethine 600mg per day.

Drug: Pantethine

Interventions

Coenzyme A DRUG

Coenzyme A 400mg per day.

Coenzyme A 400mg

Pantethine DRUG

Pantethine 600mg per day.

Pantethine 600mg

Eligibility Criteria

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

You may qualify if:

• TG 2.3～6.5mmol/l meeting the China National Cholesterol Education Programme diagnostic criteria of hyperlipidemia;
• years of age;
• women of childbearing potential not using pharmacological or mechanical contraception or with a negative pregnancy test.

You may not qualify if:

• TC \>7.0 mmol/l;
• Body Mass Index \> 30 kg/m2
• drug induced secondary hypercholesterolemia (such as dibenzothiazine, contraceptive agent or adrenal cortex hormone)
• pregnancy
• acute coronary syndrome, acute myocardial infarction or undergone a revascularization procedure within 6 months
• acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 3-fold the upper normal limit
• nephrotic syndrome or serum creatinine (Cr) (≥179 µmol/L) and creatine phosphokinase (CK) more than 3-fold the upper normal limit
• primary hypothyroidism
• psychiatric patients and HIV-infected patients
• poorly controlled hypertension, as indicated by a Systolic Blood Pressure \>180 mmHg or Diastolic Blood Pressure \>110 mmHg
• Type I diabetes mellitus（DM）, poorly controlled Type II DM (BS\>11.0 mmol/L ) or Type II DM with LDL-C \>2.6 mmol/L.Patients using immunosuppressive drugs, prohibited medication or other lipid-lowing drugs were also excluded. Subjects were also ineligible for the study if they had any severe disease.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

1st Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Hyperlipoproteinemias

Interventions

Coenzyme A; pantethine

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Junzhu Chen, MD

  Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 10, 2013
• First Posted: March 14, 2013
• Study Start: July 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

CN (1)