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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01362218

Enrollment

107

Registered

2011-05-30

Start date

2010-10-31

Completion date

2012-04-30

Last updated

2013-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elevated LDL Cholesterol

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.

Interventions

DRUGCardiovascular 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.

DRUGSimvastatin, ramipril, acetylsalicylic acid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
• Difference in triglyceride 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026