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Ramipril 10 mg/Day Prevention

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Sanofi

Status and phase

Completed
Phase 4

Conditions

Atherosclerosis

Treatments

Drug: Ramipril

Study type

Interventional

Funder types

Industry

Identifiers

NCT01053910
HOE498_4099

Details and patient eligibility

About

The objective is to investigate the safety of ramipril 10 mg/day used in prevention of cardiovascular events in high-risk patients, including the criteria of the HOPE study.

Enrollment

1,012 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • History of coronary artery disease,
  • Stroke
  • Stable heart failure
  • Peripheral vascular disease, or diabetes with at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, cigarette smoking, or documented microalbuminuria).

Exclusion criteria

  • Non stabilized or NYHA grade IV heart failure patients

  • Hemodynamically significant primary valvular or outflow tract obstruction (eg. mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve)

  • Constrictive pericarditis.

  • Complex congenital heart disease.

  • Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic cardiac arrhythmias including ventricular tachycardia are not an exclusion criterion).

  • Planned cardiac surgery or angioplasty within 3 months (patient may be reconsidered for the trial after the procedure).

  • Cor pulmonale.

  • Heart transplant recipient.

  • Significant renal disease defined as:

    • Renal artery stenosis;
    • Creatine clearance <0.6 ml/second or serum creatinine≥ 200 mEq/L (≥2.26 mg/dl)
    • Overt nephropathy: ≥1 plus proteinuria on dipstick or urinary albumin excretion > 200 micrograms/minute (300 mg/24 hrs)
    • Hyperkalemia; K>5.5 mEq/L.
  • Patient is simultaneously taking another experimental drug.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

1,012 participants in 1 patient group

Ramipril
Experimental group
Description:
Duration of treatment: 2 months 7 first days: 1.25mg once daily in patients with stable heart failure and 7 days 2.5mg once daily or 14 first days:2.5mg once daily in patients without heart failure for 14 more days:5mg once daily maintenance therapy for 1 month: 10 mg (5mg, 2 tablets)
Treatment:
Drug: Ramipril

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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