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

Ferrer

Status and phase: Terminated; Phase 2

Conditions: Hypertension

Treatments: Drug: Ramipril; Drug: Combination pill

Study type: Interventional

Funder types: Industry

Identifiers

NCT01005290

P-080646-01

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

38 participants in 2 patient groups

Combination pill

Experimental group

Description:

A once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.

Treatment:

Drug: Combination pill

Ramipril

Active Comparator group

Description:

A once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks.

Treatment:

Drug: Ramipril