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Statins

CV Fixed Dose Combination Pill AAR for High Blood Pressure

Phase 2
Waitlist Available
Led By Ronald Surowitz
Research Sponsored by Ferrer Internacional S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 months.
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in LDL cholesterol levels between the baseline (week 4) and the final visit (week 8).
Difference in the adjusted mean 24-h systolic blood pressure results using ABPM between the baseline (week 0) and the final visit (week 8).
Secondary outcome measures
Difference in HDL cholesterol levels between the basal and the final visits.
Difference in Very Low-Density Lipoprotein (VLDL) cholesterol levels between the basal and the final visits.
Difference in the adjusted mean 24-h diastolic blood pressure results (using ABPM) between the basal and the final visits.
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: CV Fixed Dose Combination Pill AARExperimental Treatment1 Intervention
Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg).
Group II: AtorvastatinActive Control1 Intervention
Atorvastatin 40 mg (Lipitor®).
Group III: RamiprilActive Control1 Intervention
Ramipril 10 mg (Altace®).

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Who is running the clinical trial?

Ferrer Internacional S.A.Lead Sponsor
25 Previous Clinical Trials
11,140 Total Patients Enrolled
Ronald SurowitzPrincipal InvestigatorHealth Awareness, Inc
1 Previous Clinical Trials
628 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2016. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02791958.
All > Cardiovascular > Lipitor
~58 spots leftby Apr 2025
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