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Cross-over Study of Coronary Risk Factors With a Polypill

NCT05030818 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-08-05

No results posted yet for this study

Summary

Open-label, randomized, cross-over study conducted in a single center, applied to patients receiving a polypill with 100 mg of acetyl salicylic acid and different doses of ramipril and atorvastatin for indication of secondary prevention according to clinical practice, with objective of analyzing the level of systolic blood pressure and LDL-cholesterol in the same patient in 2 different periods: one under treatment of 3 months with the polypill and another of 3 months with the components separately.

Conditions

Interventions

DRUG

Polypill of acetylsalicylic acid, ramipril and atorvastatin

Administration of acetylsalicylic acid, ramipril and atorvastatin in a polypill during 3 months more

DRUG

Drugs taken separately: acetylsalicylic acid, ramipril and atorvastatin

Patients will be receiving during 3 months more the same components acetylsalicylic acid, ramipril and atorvastatin than with the polypill

Sponsors & Collaborators

  • Fundación EPIC

    lead OTHER

Principal Investigators

  • Iñigo Lozano, MD, PHD · Hospital de Cabueñes, Gijon

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2026-03-30
Completion
2026-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT05030818 on ClinicalTrials.gov