A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferrer Internacional S.A.
• Treatments: Aspirin; Ramipril; Simvastatin

Criteria

Inclusion Criteria:

• Subjects will be ≥18 years old

• Previously untreated systolic pressure result of ≥120<160 mmHg and diastolic pressure result of ≥80<100 mmHg

Exclusion Criteria:

• Subjects must not have previously received any anti-hypertensive medication

• must not have a systolic pressure <120 mmHg or ≥160 mmHg and diastolic pressure result of <80 mmHg or ≥100 mmHg

• must not have had a previous coronary artery bypass graft (CABG)

• must not have had a previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent

• must not have severe congestive heart failure (New York Heart Classification [NYHC] III-IV).