Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol

Phase 2

Terminated

• Conditions: Elevated LDL Cholesterol
• Interventions: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril); Drug: Simvastatin, ramipril, acetylsalicylic acid

• Registration Number: NCT01362218
• Lead Sponsor: Ferrer Internacional S.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-30
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Dose Combination Pill	Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)	A fixed dose combination of acetylsalicylic acid, simvastatin, and ramipril Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
Simvastatin	Simvastatin, ramipril, acetylsalicylic acid	Simvastatin given together with the reference drugs ramipril and acetylsalicylic acid

Primary Outcome Measures

Name	Time	Method
Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.	Day 56

Secondary Outcome Measures

Name	Time	Method
• 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

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain