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Pharmacodynamic Equivalence of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular (CV) Polypill Acetylsalicylic Acid-Atorvastatin-Ramipril (AAR) as Compared to Monotherapy

NCT02791958 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2017-04-10

No results posted yet for this study

Summary

This study is to compare the pharmacodynamics of a Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) and the respective reference products, atorvastatin (Lipitor®) 40 mg and ramipril (Altace®) 10 mg.

Conditions

Interventions

DRUG

Cardiovascular Fixed Dose Combination Pill AAR

A once daily oral dose of the Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) for 4 weeks.

DRUG

Atorvastatin 40 mg

A once daily oral dose of atorvastatin 40 mg (Lipitor®) for 4 weeks

DRUG

Ramipril 10 mg

A once daily oral dose of ramipril 10 mg (Altace®) for 4 weeks

Sponsors & Collaborators

  • Ferrer Internacional S.A.

    lead INDUSTRY

Principal Investigators

  • Ronald Surowitz · Health Awareness, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United States

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 NCT02791958 on ClinicalTrials.gov