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

Stopped early · Phase 2

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT01005290

Run by

Ferrer Internacional S.A.

People needed

38

Starts

2009-10-01

Expected to finish

2010-10-01

Last updated by the study team

2012-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be ≥18 years old
• Previously untreated systolic pressure result of ≥120<160 mmHg and diastolic pressure result of ≥80<100 mmHg

You may not qualify if…

• 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).

Where it is running

• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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