NCT00000539

Brief Summary

To evaluate, in asymptomatic and symptomatic participants with peripheral arterial disease, the feasibility of recruitment and adherence, efficacy and safety of HDL-C raising along with effective control of LDL-C levels, antioxidant therapy, antithrombotic therapy, and their combinations.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1992

Longer than P75 for phase_3

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

September 1, 1992

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

July 12, 2016

Status Verified

January 1, 2006

First QC Date

October 27, 1999

Last Update Submit

July 11, 2016

Conditions

Arterial Occlusive DiseasesCardiovascular DiseasesHeart DiseasesVascular DiseasesDiabetes Mellitus

Interventions

niacinDRUG
pravastatinDRUG
beta-caroteneDRUG
vitamin EDRUG
dietary supplementsBEHAVIORAL
vitamin CDRUG
warfarinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women with symptomatic or asymptomatic peripheral arterial disease.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (4)

  • Egan DA, Garg R, Wilt TJ, Pettinger MB, Davis KB, Crouse J, Herd JA, Hunninghake DB, Sheps DS, Kostis JB, Probstfield J, Waclawiw MA, Applegate W, Elam MB. Rationale and design of the Arterial Disease Multiple Intervention Trial (ADMIT) pilot study. Am J Cardiol. 1999 Feb 15;83(4):569-75. doi: 10.1016/s0002-9149(98)00915-1.

    PMID: 10073863BACKGROUND

  • Elam MB, Hunninghake DB, Davis KB, Garg R, Johnson C, Egan D, Kostis JB, Sheps DS, Brinton EA. Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease: the ADMIT study: A randomized trial. Arterial Disease Multiple Intervention Trial. JAMA. 2000 Sep 13;284(10):1263-70. doi: 10.1001/jama.284.10.1263.

    PMID: 10979113BACKGROUND

  • Garg R, Elam MB, Crouse JR 3rd, Davis KB, Kennedy JW, Egan D, Herd JA, Hunninghake DB, Johnson WC, Kostis JB, Sheps DS, Applegate WB. Effective and safe modification of multiple atherosclerotic risk factors in patients with peripheral arterial disease. Am Heart J. 2000 Nov;140(5):792-803. doi: 10.1067/mhj.2000.110090.

    PMID: 11054628BACKGROUND

  • Chesney CM, Elam MB, Herd JA, Davis KB, Garg R, Hunninghake D, Kennedy JW, Applegate WB. Effect of niacin, warfarin, and antioxidant therapy on coagulation parameters in patients with peripheral arterial disease in the Arterial Disease Multiple Intervention Trial (ADMIT). Am Heart J. 2000 Oct;140(4):631-6. doi: 10.1067/mhj.2000.109648.

    PMID: 11011338BACKGROUND

MeSH Terms

Conditions

Arterial Occlusive DiseasesCardiovascular DiseasesHeart DiseasesVascular DiseasesDiabetes Mellitus

Interventions

NiacinPravastatinbeta CaroteneVitamin EDietary SupplementsAscorbic AcidWarfarin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesPigments, BiologicalBiological FactorsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydrates4-HydroxycoumarinsCoumarins

Study Officials

  • Kathryn Davis

    Statistics and Epidemiology Research Corporation

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1992

Study Completion

March 1, 1999

Last Updated

July 12, 2016

Record last verified: 2006-01