Working... Menu

Ramipril 10 mg/Day Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01053910
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : January 22, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: Ramipril Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1012 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2003
Actual Primary Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril

Arm Intervention/treatment
Experimental: Ramipril
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)
Drug: Ramipril
tablet of Ramipril once daily

Primary Outcome Measures :
  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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01053910

Layout table for location information
Sanofi-Aventis Administrative Office
Dhaka, Bangladesh
Sponsors and Collaborators
Layout table for investigator information
Study Director: Rezaul Farid Khan, Medical Director Sanofi

Layout table for additonal information
Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT01053910     History of Changes
Other Study ID Numbers: HOE498_4099
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: February 2009

Additional relevant MeSH terms:
Layout table for MeSH terms
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents