Study Stopped
Per sponsor's decision
Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol
Cardiovascular Fixed Combination Pill ASR: Pharmacodynamic Clinical Trial of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril (Cardiovascular Polypill); LDL Cholesterol
1 other identifier
interventional
107
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedApril 24, 2013
April 1, 2013
1.5 years
May 26, 2011
April 23, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.
Day 56
Secondary Outcomes (4)
• 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
Study Arms (2)
Fixed Dose Combination Pill
EXPERIMENTALA fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
Simvastatin
ACTIVE COMPARATORSimvastatin given together with the reference drugs ramipril and acetylsalicylic acid
Interventions
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
Eligibility Criteria
You may qualify if:
- Male or female subjects aged ≥18 and \<75 years.
- Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid lowering drug for the last 4 weeks.
- LDL-cholesterol ≥130 and ≤220 mg/dL.
- Systolic blood pressure ≥120 and \<160 mmHg and diastolic blood pressure ≥70 and \<100 mmHg.
- Provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic
Barcelona, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 30, 2011
Study Start
October 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 24, 2013
Record last verified: 2013-04