Per sponsor's decision
Cardiovascular Fixed Combination Pill ASR: Pharmacodynamic Clinical Trial of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril (Cardiovascular Polypill); LDL Cholesterol
Sponsor study identifier
interventional
107
1 country
1
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
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 the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
May 26, 2011
Actual (reported)May 30, 2011
Actual (reported)April 2012
Actual (reported)April 2012
Actual (reported)Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.
Day 56
• Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period.
Day 56
• Difference in HDL-cholesterol levels between the basal and the final visit of treatment period.
Day 56
• Difference in total cholesterol levels between the basal and the final visit of treatment period.
Day 56
• Difference in triglyceride levels between the basal and the final visit of treatment period
Day 56
A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid
A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks.
A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 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 recordGrouped treatment entry
Simvastatin, ramipril, acetylsalicylic acid
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHospital Clinic
Barcelona, Spain
107 participants (actual enrollment reported by the registry).
First Submitted
May 26, 2011
First Posted
May 30, 2011
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Pharmacodynamic Equivalence of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular (CV) Polypill Acetylsalicylic Acid-Atorvastatin-Ramipril (AAR) as Compared to Monotherapy
Linked from the registry description. Each source intervention is retained as reported.
In: Simvastatin, ramipril, acetylsalicylic acid
In: Simvastatin, ramipril, acetylsalicylic acid
In: Simvastatin, ramipril, acetylsalicylic acid
Contact the study team to confirm eligibility.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)Last Updated
April 24, 2013
Record last verified: 2013-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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