Ramipril 10 mg/Day Prevention

NCT01053910 | Completed Phase 4

• 1 other identifier: HOE498_4099
• Study Type: interventional
• Target: 1,012
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Ramipril

EXPERIMENTAL

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

Interventions

Ramipril DRUG

tablet of Ramipril once daily

Ramipril

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rezaul Farid Khan, Medical Director

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 22, 2010
• Study Start: October 1, 2003
• Primary Completion: July 1, 2005
• Last Updated: January 22, 2010

Record last verified: 2009-02

Locations

BA (1)