IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)

PHASE3CompletedINTERVENTIONAL
Enrollment

18,144

Participants

Timeline

Start Date

October 17, 2005

Primary Completion Date

September 18, 2014

Study Completion Date

September 18, 2014

Conditions
HypercholesterolemiaMyocardial Infarction
Interventions
DRUG

ezetimibe/simvastatin

Ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).

DRUG

simvastatin

Simvastatin 40 mg per day from randomization through the end of participation. As per the original protocol, if LDL-C response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped).

DRUG

Placebo for simvastatin 40 mg

one or two tablets orally daily

DRUG

Placebo for ezetimibe 10 mg/simvastatin 40 mg combination

one tablet orally daily.

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00202878 - IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103) | Biotech Hunter | Biotech Hunter