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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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