NCT00345657

Brief Summary

The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

July 1, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
Last Updated

June 28, 2006

Status Verified

June 1, 2006

First QC Date

June 27, 2006

Last Update Submit

June 27, 2006

Conditions

HyperlipidemiaMixed HyperlipidemiaDyslipidemia

Keywords

HyperlipidemiaDyslipidemiaNiacinHydroxymethylglutaryl-CoA Reductase InhibitorsCombination lipid therapyLovastatin

Outcome Measures

Primary Outcomes (2)

  • Lipid parameter change at 3 and 6 months

  • Percent of patients achieving ATP III LDL goals at 3 and 6 months

Interventions

Niacin Extended Release/LovastatinDRUG

Eligibility Criteria

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

You may qualify if:

  • \>18 years old with CAD or risk factors for CAD
  • under standard care at Family Medical Care of Tulsa
  • not at LDL goal per ATP III guidelines

You may not qualify if:

  • pregnancy/lactating
  • liver disease
  • allergies to statin or niacin
  • active peptic ulcer disease
  • previous treatment with combination therapy for dyslipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Medical Care of Tulsa

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

HyperlipidemiasHyperlipoproteinemia Type IIDyslipidemias

Interventions

Lovastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemias

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Jason A Logan, MD

    In His Image Family Medicine Residency

    PRINCIPAL INVESTIGATOR

  • Edward Rylander, MD

    In His Image Family Medicine Residency

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

July 1, 2003

Study Completion

May 1, 2004

Last Updated

June 28, 2006

Record last verified: 2006-06

Locations

US(1)