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lovastatin

Phase 2

Atherosclerosis | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Dec 11, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment270

FDA Designations

No designations recorded

Clinical trial landscape

lovastatin · 1 trial · 2 indications

Phase 2 1
NCT00116870MARS - Monitored Atherosclerosis Regression StudyAtherosclerosis
COMPLETED270 Analytics
PHASE2COMPLETED
MARS - Monitored Atherosclerosis Regression Study
AtherosclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

the average (per-patient) change from baseline in percent diameter stenosis in all lesions that showed 20% diameter stenosis at baseline or at follow-up as evaluated by quantitative coronary angiography

Secondary Endpoints

average (per-patient) change in minimum lumen diameter assessed by quantitative angiography
the global change score assessed by a human panel
the proportion of patients with progression or regression of disease assessed by quantitative coronary angiography
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
lovastatinDRUG -
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Eligibility Criteria

Age Range21 Years to 67 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Angiography within 17 weeks of randomization showing patient is at high risk for coronary artery disease but not a candidate for coronary artery graft surgery * Men and women ages 21 through 67 years * Mean plasma cholesterol levels from the first two screening visits in the r...

Countries:United States
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