Open label study to assess the efficacy, safety and dosing of clevidipine in children undergoing surgery.

Phase 1

• Conditions: Blood pressure management in pediatric patients in the perioperative setting. Treatment of hypertensive patients and normotensive patients who require lowering of blood pressure for the procedure.; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2013-001268-44-Outside-EU/EEA
• Lead Sponsor: Chiesi USA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-10
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patient must be less than 18 years
2. Written informed consent obtained before initiation of any study-related procedures
3. The enrolling physician determines that patient will likely require a 15% reduction in BP during the perioperative course
4. Intra-arterial line available for blood pressure monitoring
5. Surgical procedure requiring at minimum 1 hour of anesthesia, in which IV antihypertensive therapy to control BP for at least 30 minutes is anticipated
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Administration of an IV or oral antihypertensive agent within 2 hours prior to study drug administration
2. Congenital heart disease described as single ventricle
3. Evidence of liver failure, severe liver disease, pulmonary disease (e.g. uncontrolled asthma), hyperlipidemia, lipoid nephrosis, lipid dysfunction or acute pancreatitis
4. Allergy to soya bean oil or egg lecithin
5. Known to be intolerant to calcium channel blockers
6. Hemophilia or blood coagulation disorders
7. Any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
8. Clinically significant abnormal physical findings at the screening evaluation
9. Any serious surgical or medical condition which, in the opinion of the investigator, is likely to interfere with study procedures or with the pharmacokinetics or pharmacodynamics of the study drug
10. Patient is terminally ill (death likely to occur within 48 hours)
11. Use of Methylphenidate, Calcium Channel blockers, Aripiprazole and other atypical anti psychotics and anti-hypertensives used for BP control within 2 hours prior to study drug initiation
12. Positive serum or urine pregnancy test for any female of childbearing potential
13. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
14. Patients who, for any reason, are deemed by the Investigator to be inappropriate for this study
15. Patient is a relative of the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff directly involved in the conduct of the study
16. Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified