Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol
NCT ID: NCT01362218
Last Updated: 2013-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
107 participants
INTERVENTIONAL
2010-10-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Fixed Dose Combination Pill
A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks.
Simvastatin
Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid
Simvastatin, ramipril, acetylsalicylic acid
A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks
Interventions
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Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks.
Simvastatin, ramipril, acetylsalicylic acid
A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Ferrer Internacional S.A.
INDUSTRY
Responsible Party
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Locations
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Hospital Clinic
Barcelona, , Spain
Countries
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Other Identifiers
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P-100820-01
Identifier Type: -
Identifier Source: org_study_id
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