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Anti-Oxidant Therapy In Chronic Renal Insufficiency (ATIC) Study

NCT00384618 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2006-10-06

No results posted yet for this study

Summary

The ATIC study is a randomised, double- blind, placebo-controlled trial in which the effects of oxidative stress-lowering treatment on vascular function and structure are studied in patients with chronic non-diabetic renal failure who are free from manifest arterial occlusive disease. Participants in the trial were randomised to active treatment consisting of add-on therapy with pravastatin, vitamin E and homocysteine-lowering therapy, or to placebo. Subjects not using angiotensin converting enzyme inhibitors (ACE-inhibitors) or angiotensin receptor blockers (ARBs) at inclusion were put on ACE-inhibitors for at least two weeks before the baseline measurement and randomisation. Those who were on ARBs continued their ARBs. We excluded individuals with diabetes mellitus (ADA criteria), active vasculitis, nephrotic syndrome (\>3gr/24hr urine protein), renal transplantation, fasting total cholesterol \> 7 mmol/L, cholesterol-lowering therapy within three months prior to inclusion or known ischemic cardiac, cerebrovascular or peripheral arterial disease. Ninety-three patients (out of 118 eligible patients) took part in the study and written informed consent was obtained from all participants.

Conditions

Interventions

DRUG

pravastatin

DRUG

vitamin E

Sponsors & Collaborators

  • Medical Research Foundation, The Netherlands

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Prof. Peter M ter Wee, MD, PhD · Depratment of Nephrology, VU University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Completion
2005-08-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

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 NCT00384618 on ClinicalTrials.gov