Familial Atherosclerosis Treatment Study

NCT00000512 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2015-12-03

No results posted yet for this study

Summary

To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.

Conditions

Interventions

DRUG

lovastatin

Lovastatin was begun at a dose of 20 mg twice a day (in the morning and at bedtime). If the LDL cholesterol level did not fall below 3.1 mmol per liter after three months, the dose of lovastatin was increased to 40 mg twice a day.

DRUG

colestipol

Colestipol was begun at a dose of 5 g three times a day with meals and increased to 10 g three times a day after 10 days, unless side effects delayed the increase. Psyllium hydrophic mucilloid (Metamucil) was provided if dietary bran was insufficient to control constipation.

DRUG

niacin

Niacin was started at 125 mg twice a day and gradually increased to 500 mg four times a day (with meals and at bedtime) at one month and 1 g four times a day at two months. If the LDL cholesterol level did not fall below 3.1 mmol per liter (120 mg per deciliter) after three months, the dose of niacin was increased to 1.5 g (three tablets) four times a day, but no further.

OTHER

Placebo for colestipol

Placebo for colestipol.

OTHER

Placebo for lovastatin

Placebo for lovastatin

Sponsors & Collaborators

Principal Investigators

  • B. Greg Brown, M.D., Ph.D · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
62 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1984-01-31
Primary Completion
1989-08-31
Completion
1989-08-31

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Entities

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 NCT00000512 on ClinicalTrials.gov