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The HDL Particle Protection Study

NCT02125682 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-02-01

No results posted yet for this study

Summary

Atorvastatin is a statin that significantly decreases LDL level. At 10 mg/day, atorvastatin increases HDL level by 4-5%. At 80 mg/day, atorvastatin does not increase HDL level. However, atorvastatin is more protective at 80 mg/day than at 10 mg/day. This is due to a better reduction in LDL level at 80 mg, but we also think that 80 mg/day of atorvastatin is superior to 10 mg/day in improving the QUALITY of HDL, such as improving HDL particle number and function (better anti-oxydant activity)

Conditions

  • Dyslipidemia in Patients With Diabetes Mellitus

Interventions

DRUG

atovastatin 10 mg/day

patients will receive 10 mg of atorvastatin daily for 8 weeks, then wash out for 6 weeks then cross over to atorvastatin 80 mg daily for 8 weeks

DRUG

Atorvastatin 80 mg/day

patients will receive 80 mg of atorvastatin daily for 8 weeks, then wash out for 6 weeks then cross over to atorvastatin 10 mg daily for 8 weeks

Sponsors & Collaborators

  • Nouvelle Société Française d'Athérosclérose

    collaborator UNKNOWN

  • Pfizer

    collaborator INDUSTRY

  • Hotel Dieu de France Hospital

    lead OTHER

Principal Investigators

  • M. John Chapman, PhD · INSERM Pitié Salpetriere, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2017-05-14
Completion
2017-05-14

Countries

  • Lebanon

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02125682 on ClinicalTrials.gov