MedTrace Logo

(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol

NCT00526058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-09-14

Study results available
· View outcomes & findings →

Summary

The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use under the approved indication of the acute reduction of LDL-cholesterol from the plasma in populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated.

Conditions

Interventions

DEVICE

Secura then Futura

Randomized to 6 bi-monthly H.E.L.P. therapy treatments with the Plasmat® Secura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Futura apheresis system.

DEVICE

Futura then Secura

Randomized to 6 bi-monthly H.E L.P. therapy treatments with the Plasmat® Futura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Secura apheresis system.

Sponsors & Collaborators

  • B. Braun Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick Moriarty, M.D. · University of Kansas Medical Center

  • Paul Thompson, M.D. · Hartford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-10-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00526058 on ClinicalTrials.gov