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
Recruiting in Palo Alto (17 mi)
+35 other locations
RS
Overseen byRonald Surowitz
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Ferrer Internacional S.A.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
RS
Ronald Surowitz
Principal Investigator
Health Awareness, Inc
Eligibility Criteria
Inclusion Criteria
Male or female patients aged ≥18 and <75 years.
Patients with Stage 1 (SBP/DBP: 140-159/90-99 mmHg) or Stage 2 (SBP/DBP: ≥160/≥100 mmHg) hypertension, either untreated or after a wash out period.
Patients with an LDL cholesterol level of ≥100 mg/dL and, either untreated or after the wash out period.
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Treatment Details
Interventions
- Atorvastatin (Statins)
- Cardiovascular Fixed Dose Combination Pill AAR (Hormone Therapy)
- Ramipril (ACE inhibitor)
Participant Groups
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®).
Atorvastatin is already approved in Canada, Japan, China, Switzerland for the following indications:
Approved in Canada as Lipitor for:
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Prevention of cardiovascular disease
Approved in Japan as Lipitor for:
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
Approved in China as Lipitor for:
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
Approved in Switzerland as Lipitor for:
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Deleon Research, PLLCPlano, TX
Physician PrimeCare Research Institute, PLLC dba HSan Antonio, TX
Progressive Medical ResearchPort Orange, FL
Louisville Metabolic and Atherosclerosis ResearchLouisville, KY
More Trial Locations
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Who Is Running the Clinical Trial?
Ferrer Internacional S.A.
Lead Sponsor
Trials
27
Patients Recruited
11,700+