Ramipril 10 mg/Day Prevention

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01053910

Enrollment

1012

Registered

2010-01-22

Start date

2003-10-31

Completion date

Unknown

Last updated

2010-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Brief summary

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.

Interventions

DRUGRamipril

tablet of Ramipril once daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Number of patient reaching the 10mg/day dose level	30 days after the treatment start
Overall number of adverse events	at day 7 (visit 2), day 15 (visit 3), day 30 (visit 4), day 45 (visit 5) and day 60 (final visit)

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026