Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Study of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril in Subjects With Elevated LDL Cholesterol
Sponsor study identifier
interventional
36
1 country
1
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2011
Actual (reported)Study Completion
March 2011
Actual (reported)This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 23, 2009
Actual (reported)October 30, 2009
Actual (reported)March 2011
Actual (reported)March 2011
Actual (reported)August 31, 2012
Actual (reported)The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.
Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.
Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.
Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
Once daily oral dose of combination of acetylsalicylic acid, simvastatin, and ramipril (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 or 10 mg ramipril)
Once daily oral dose of Simvastatin 40 mg
A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks.
A once daily oral dose of simvastatin for 12 weeks.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordMount Sinai Medical Center
New York, New York, NY 10029-6574, United States
Early termination leading to small numbers of subjects analyzed.
36 participants (actual enrollment reported by the registry).
First Submitted
October 23, 2009
First Posted
October 30, 2009
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Simvastatin For Intracerebral Hemorrhage Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 2011
Actual (reported)Study Completion
March 2011
Actual (reported)Last Updated
August 31, 2012
Results First Posted
August 31, 2012
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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