NCT01071525

Brief Summary

  1. 1.Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease in oxidative stress and a decrease in the atherogenecity in blood samples of the patients.
  2. 2.A possible correlation between oxidative stress in hypercholesterolemic patients taking niacin to clinical hypercholesterolemia parameters is possible.
  3. 3.Using a novel biomarker will enable a precise detection of the change in the oxidative stress in hypercholesterolemic patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 1, 2010

Status Verified

February 1, 2010

Enrollment Period

4 months

First QC Date

February 18, 2010

Last Update Submit

February 25, 2010

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Effect on oxidative stress

    three months

Study Arms (2)

Niacin

ACTIVE COMPARATOR

Hypercholesterolemic patients with high-density lipoprotein (HDL) less than 40 mg% will receive Niacin\\Laropiprant.

Drug: Niacin\Laropiprant

Control

NO INTERVENTION

Maching subjects will receive no medication, Blood tests will be drawn for laboratory tests.

Drug: Niacin\Laropiprant

Interventions

Niacin\LaropiprantDRUG

Hypercholesterolemic patients with low HDL will receive Niacin\\Laropiprant

ControlNiacin

Eligibility Criteria

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

You may qualify if:

  • Hypercholesterolemia,
  • age above eighteen

You may not qualify if:

  • Treatment with fibrates,
  • Pregnant/Breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Liz Phima

    Study Coordinator

    STUDY DIRECTOR

Central Study Contacts

Shadi Hamoud, Dr

CONTACT

+972-523591876s_hamoud@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

March 1, 2010

Record last verified: 2010-02

Locations

IL(1)