The Effects of Coenzyme A on Serum Lipids in Patients With Hyperlipidemia

NCT01645046 | Completed Phase 2 DMC

• 1 other identifier: 2008MMXX2CoA005
• Study Type: interventional
• Target: 294
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A （CoA） capsule in Chinese patients with moderate dyslipidemia.

Conditions

Hyperlipoproteinemia

Outcome Measures

Primary Outcomes (1)

• The changes of TG levels.

  4 and 8 weeks after administration.

Secondary Outcomes (1)

• The changes of TC, LDL-C, and HDL-C levels.

  4 and 8 weeks after administration.

Study Arms (3)

Coenzyme A 200mg

ACTIVE COMPARATOR

Coenzyme A 200mg per day.

Drug: Coenzyme A

Placebo

PLACEBO COMPARATOR

Capsule without coenzyme A.

Drug: Placebo

Coenzyme A 400mg

ACTIVE COMPARATOR

Coenzyme A 400mg per day.

Drug: Coenzyme A

Interventions

Coenzyme A DRUG

Coenzyme A 200mg per day.

Also known as: Low dose coenzyme A therapy.

Coenzyme A 200mg

Placebo DRUG

Capsule without coenzyme A.

Also known as: Controls.

Placebo

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.

You may not qualify if:

• TC \>7.5 mmol/l or LDL-C \>3.6 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

MeSH Terms

Conditions

Hyperlipoproteinemias

Interventions

Coenzyme A

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 17, 2012
• First Posted: July 19, 2012
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 19, 2012

Record last verified: 2012-07