CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 146 enrolled
Drug / intervention
lovastatin +4 moredrug
Likely dose
lovastatin 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000512
NCT00000512Phase 3Completed

Familial Atherosclerosis Treatment Study

University of Washington·interventional·Posted Oct 28, 1999·Updated Dec 3, 2015

In Brief

A Phase 3 clinical trial evaluating lovastatin, colestipol, and 3 other interventions for Cardiovascular Diseases and 4 related conditions. Completed, enrolled 146 participants.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 3CompletedFinished
198319841985198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 28, 1999
Enrollment StartJan 1, 1984
Primary CompletionAug 1, 1989
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 26.7 years ago

Interventions

lovastatindrug

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.

colestipoldrug

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.

niacindrug

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.

Placebo for colestipolother

Placebo for colestipol.

Placebo for lovastatinother

Placebo for lovastatin