Safety Evaluation of Use Sodic Enoxaparin

NCT00673426 | Completed Phase 3

• 1 other identifier: ENOBLA0108
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate safety, not inferiority clinical and pharmacodynamic profile of the drug Enoxaparin Sodium produced by laboratory Blausiegel when compared with Clexane product, produced by Laboratory Sanofi-Aventis in 60 patients with Chronic Renal Desease.

Conditions

Kidney Disease

Keywords

enoxaparin; chronic renal disease; Anticoagulant activity of enoxaparin sodic

Study Arms (1)

A

EXPERIMENTAL

Biological: Enoxaparin sodic

Interventions

Enoxaparin sodic BIOLOGICAL

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of both sexes, regardless of colour or social class;
• Above 18 years age, with good clinical features, to medical criterion;
• Patients who agreed to participate and signed the Informed Consent;
• Patients with Chronic Kidney Disease in hemodialysis treatment (3 times per week);
• Patients with clearance of creatinine \<30ml/min;
• Patients with details of anticoagulants during hemodialysis.

You may not qualify if:

• Not agree to the terms described in Informed Consent;
• Volunteers bearers of the sensitivity enoxaparin sodium;
• Volunteers Patients with hypersensitivity to benzyl alcohol;
• Volunteers with a history of bleeding or disease that change of blood clotting could aggravate or terminate the clinical picture, such as tables of gastric ulcer;
• Volunteers with a history of peptic ulcer;
• Patients with body mass index greater than 30;
• Patients with cancer because of the possibility of compromising the function of the variable clotting;
• Patients in a period of post-pregnancy or childbirth;
• Patients with genetic abnormality of the system of coagulation;
• Polytraumatized patients;
• Patients in use of glucocorticoids for at least 1 month;
• Patients in use of other anticoagulants;
• Patients with high rate of bleeding;
• Patients undergo any surgery performed less than 15 days due to the risk of the formation of bruising at the site of surgery.
• Hypertension above 140/90 mmHg

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Clinica TOP Nefrologia e Diálise

Americana, Brazil

Location

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 7, 2008

Record last verified: 2008-01

Locations

BR (1)