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Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

NCT01362218 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2013-04-24

No results posted yet for this study

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.

Conditions

  • Elevated LDL Cholesterol

Interventions

DRUG

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.

DRUG

Simvastatin, ramipril, acetylsalicylic acid

A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks

Sponsors & Collaborators

  • Ferrer Internacional S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362218 on ClinicalTrials.gov