NCT00847782

Brief Summary

The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 5, 2009

Status Verified

November 1, 2009

Enrollment Period

6 months

First QC Date

February 6, 2009

Last Update Submit

November 4, 2009

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Serum PCSK9 concentration

    Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled

Secondary Outcomes (4)

  • Serum LDL cholesterol concentration

    Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

  • Serum HDL cholesterol concentration

    Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

  • Serum TG concentration

    Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

  • Serum Apo B concentration

    Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects

Study Arms (3)

Blood draw (Group 1)

OTHER

Normocholesterolemic Subjects Normal Healthy Volunteers

Procedure: Blood draw

Blood draw (Group 2)

OTHER

Hypercholesterolemic Subjects

Procedure: Blood draw

Blood draw (Group 3)

OTHER

Hypercholesterolemic Subjects with Statin Treatment

Procedure: Blood draw

Interventions

Blood drawPROCEDURE

1 day

Blood draw (Group 1)Blood draw (Group 2)Blood draw (Group 3)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypercholesterolemia
  • Statin monotherapy

You may not qualify if:

  • Significant acute or chronic illness
  • Secondary causes of hypercholesterolemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Montreal, Quebec, H2W1R7, Canada

Location

Related Links

MeSH Terms

Conditions

Atherosclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 19, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 5, 2009

Record last verified: 2009-11

Locations

CA(1)