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lovastatin

Phase 3FDA approved

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

lovastatin development status

FDA approval on record Mar 11, 1999 as Mevacor
Approval holderMerck
ApplicationNDA019643
Highest phase Phase 3 (NCT00092846)
Phase scored for MRKPhase 2
Registered trials 5 across 3 sponsors since Sep 2004

lovastatin target and mechanism

Molecular targetHMGCR
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL503

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

lovastatin clinical trials

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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Frequently asked questions about lovastatin

What is lovastatin?

Lovastatin is a small molecule drug developed by Merck & Company, Inc. (ticker MRK) for atherosclerosis, a cardiovascular condition. It is an HMGCR inhibitor and has been studied in Phase 2 clinical development. Lovastatin is also known by its ChEMBL identifier CHEMBL503.

What is lovastatin used for in atherosclerosis?

Lovastatin is used for atherosclerosis, a condition characterized by hardening and narrowing of the arteries. It has been investigated in a Phase 2 clinical trial called the Monitored Atherosclerosis Regression Study (MARS), which enrolled 270 participants with atherosclerosis and coronary artery disease.

What does lovastatin target?

Lovastatin targets HMGCR, also known as HMG-CoA reductase. It acts as an inhibitor of this enzyme. By inhibiting HMGCR, lovastatin interferes with a key step in cholesterol biosynthesis, which is relevant to its development for atherosclerosis.

Who makes lovastatin?

Lovastatin is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the company associated with the clinical development of lovastatin for atherosclerosis.

What phase is lovastatin in?

Lovastatin is in Phase 2 clinical development for atherosclerosis. It is an investigational drug and has not been approved by the FDA for this indication. The Phase 2 trial has been completed.

What clinical trials is lovastatin in?

Lovastatin has been studied in one clinical trial: NCT00116870, titled MARS - Monitored Atherosclerosis Regression Study. This Phase 2 trial was completed, enrolled 270 participants, and was randomized and double-blind. It took place in the United States and included adults aged 21 years and older.