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OpenTrials
Completed

NCT Number: NCT01053910

Ramipril 10 mg/Day Prevention

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ramipril

Drug

tablet of Ramipril once daily

Primary outcomes

  1. Number of patient reaching the 10mg/day dose level

    Time frame: 30 days after the treatment start

  2. Overall number of adverse events

    Time frame: at day 7 (visit 2), day 15 (visit 3), day 30 (visit 4), day 45 (visit 5) and day 60 (final visit)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Multicentre Open, Non Comparative Study of the Safety of Ramipril (Tritace) 10 mg/Day in Prevention of Cardiovascular Events in High-risk Patients

Important dates

Study start
2003
Primary completion
2005
First posted
Jan 22, 2010
Registry last updated
Jan 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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