NCT02791958

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

Pharmacodynamic Equivalence Study of Ramipril 10 mg and Atorvastatin 40 mg Administered as a Cardiovascular Fixed Dose Combination Pill AAR as Compared to Monotherapy With the Reference Products Altace® 10 mg and Lipitor® 40 mg

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 528 (estimated)
• Sponsor: Ferrer Internacional S.A. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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

• Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-06-07
• Last updated: 2017-04-10

Locations

36 sites across 1 country: United States