Ramipril 10 mg/Day Prevention

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01053910
First received: January 14, 2010
Last updated: January 20, 2010
Last verified: February 2009
  Purpose

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 Intervention Phase
Atherosclerosis
Drug: Ramipril
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patient reaching the 10mg/day dose level [ Time Frame: 30 days after the treatment start ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 1012
Study Start Date: October 2003
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053910

Locations
Bangladesh
Sanofi-Aventis Administrative Office
Dhaka, Bangladesh
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Rezaul Farid Khan, Medical Director Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01053910     History of Changes
Other Study ID Numbers: HOE498_4099
Study First Received: January 14, 2010
Last Updated: January 20, 2010
Health Authority: Bangladesh:Ministry of Health & Family Welfarer

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014