Status:
COMPLETED
Study to Assess Safety and Efficacy of AQUAVAN® Injection for Sedation During Cardiac Catheterization
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
PPD Development, LP
Covance
Conditions:
Angioplasty
Coronary Catheterization
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The anticipation of pain and discomfort, a diagnosis, and other intrinsic unknowns make patients anxious both prior to and during a procedure. Therefore, the main goal of sedation with analgesia used ...
Detailed Description
This was a randomized, open-label study designed to assess the safety and efficacy of AQUAVAN® Injection (hereafter referred to as AQUAVAN) versus the reference drug, midazolam HCl (hereafter referred...
Eligibility Criteria
Inclusion
- Patient provided signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study.
- Patient was at least 18 years of age at the time of screening (Prior to Amendment 2 \[dated 04 February 2005\], the patient was required to be between 18 and 65 years of age, inclusive. Three subjects were randomized under this earlier inclusion criteria).
- If female, patient was surgically sterile, postmenopausal or not pregnant or lactating and had been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at Screening and Predosing Periods.
- Patient met American Society of Anesthesiologists (ASA)13, 14 Physical Status Classification System level I to III; and
- Patient was an inpatient or outpatient scheduled to undergo a single PC procedure.
Exclusion
- Patient had history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
- Patient did not meet nils per os (NPO) status per ASA Guideline or institution's guideline.
- Patient had a condition(s) that, in the opinion of the Investigator, could interfere with appropriate airway management.
- Patient had participated in an investigational drug study within 1 month prior to study start.
- Patient had history of mental or visual impairment that would not permit successful measurement of cognitive evaluations.
- Patient was unwilling to adhere to pre- and postprocedural instructions; or
- Patient for whom the use of fentanyl or midazolam was contraindicated.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00209547
Start Date
February 1 2004
End Date
March 1 2005
Last Update
November 7 2008
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