AngioplastyPhase 3NCT00209547
Study to Assess Safety and Efficacy of AQUAVAN® Injection for Sedation During Cardiac Catheterization
A Phase 3 study testing fospropofol disodium in people with Angioplasty and Coronary Catheterization, run by Eisai Inc..
Trial 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 during various diagnostic, therapeutic, or surgical procedures is to relieve this anxiety, discomfort, and pain, which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty, Coronary Catheterization
- What is being tested?
- fospropofol disodium
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Phase III, Randomized, Open-Label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Percutaneous Coronary (PC) Procedures
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 during various diagnostic, therapeutic, or surgical procedures is to relieve this anxiety, discomfort, and pain, which are all interrelated. The optimal level of sedation for any given patient is one that allows the patient to tolerate the procedure and provides an appropriate safety margin. This was a study designed to examine the safety and efficacy of AQUAVAN® Injection versus a commonly used approved sedative drug, midazolam HCl following pretreatment with fentanyl citrate injection (for pain relief) in producing sedation in patients undergoing single cardiac catheterization procedures.
Read the 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 to as midazolam) following pretreatment with fentanyl citrate injection (hereafter referred to as fentanyl) in producing sedation in male and female patients undergoing single PC procedures.
Screening assessments were done within 2 weeks of scheduled procedures. After completion of preprocedural sedation assessments, patients were randomly assigned to 1 of the 2 treatment groups at a 3:1 (AQUAVAN: midazolam) allocation ratio on the day of the scheduled procedure (Day 0) via an Interactive Voice Response System (IVRS). Randomization was stratified by site.
All patients, regardless of treatment group assignment, received fentanyl as an analgesic pretreatment. Supplemental doses of fentanyl could be administered if the patient reported pain or if analgesia was inadequate, as demonstrated by increased heart rate and/or blood pressure in the presence of adequate sedation. At no time was fentanyl to be administered to increase sedation levels.
AQUAVAN or midazolam was administered by intravenous (i.v.) bolus to induce a state of minimal-to-moderate (procedural) s sedation, defined as a score of ≤4 on the Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale. Supplemental doses were administered, if necessary, to increase the depth or duration of sedation. Supplemental doses were not administered if the Modified OAA/S score was ≤2 or if there was no purposeful response to stimulation. Patient and Investigator assessments were used to confirm that the depth of sedation met the goals of sedation, reduced anxiety, and awareness.
Follow-up patient assessments were conducted in a telephone interview 24 hours following treatment and during a clinic visit 2 to 5 days following treatment.
- Conditions
- Angioplasty, Coronary Catheterization
- Being tested
- fospropofol disodium
- Keywords
- AQUAVAN® Injection, Midazolam, Angioplasty, Coronary catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fospropofol disodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate that AQUAVAN was effective in providing adequate sedation in patients undergoing percutaneous coronary (PC) procedures.
Secondary outcomes (1)
Treatment-emergent adverse events, Sedation-related adverse events, and airway Assistance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioplastyStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Covance
- Investigators
- James Jones, MD,PharmD, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209547
- Sponsor's protocol ID
- 3000-0411
- Status last verified
- Nov 2008
- First submitted
- 13 Sep 2005
- Last updated
- 7 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-Label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Percutaneous Coronary (PC) Procedures
- ClinicalTrials.gov ID
- NCT00209547
- Acronym / sponsor ID
- 3000-0411
- Conditions
- Angioplasty, Coronary Catheterization
- Keywords
- AQUAVAN® Injection, Midazolam, Angioplasty, Coronary catheterization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Covance
- Study start
- Feb 2004
- Study completion
- Mar 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 during various diagnostic, therapeutic, or surgical procedures is to relieve this anxiety, discomfort, and pain, which are all interrelated. The optimal level of sedation for any given patient is one that allows the patient to tolerate the procedure and provides an appropriate safety margin. This was a study designed to examine the safety and efficacy of AQUAVAN® Injection versus a commonly used approved sedative drug, midazolam HCl following pretreatment with fentanyl citrate injection (for pain relief) in producing sedation in patients undergoing single cardiac catheterization procedures.
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 to as midazolam) following pretreatment with fentanyl citrate injection (hereafter referred to as fentanyl) in producing sedation in male and female patients undergoing single PC procedures.
Screening assessments were done within 2 weeks of scheduled procedures. After completion of preprocedural sedation assessments, patients were randomly assigned to 1 of the 2 treatment groups at a 3:1 (AQUAVAN: midazolam) allocation ratio on the day of the scheduled procedure (Day 0) via an Interactive Voice Response System (IVRS). Randomization was stratified by site.
All patients, regardless of treatment group assignment, received fentanyl as an analgesic pretreatment. Supplemental doses of fentanyl could be administered if the patient reported pain or if analgesia was inadequate, as demonstrated by increased heart rate and/or blood pressure in the presence of adequate sedation. At no time was fentanyl to be administered to increase sedation levels.
AQUAVAN or midazolam was administered by intravenous (i.v.) bolus to induce a state of minimal-to-moderate (procedural) s sedation, defined as a score of ≤4 on the Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale. Supplemental doses were administered, if necessary, to increase the depth or duration of sedation. Supplemental doses were not administered if the Modified OAA/S score was ≤2 or if there was no purposeful response to stimulation. Patient and Investigator assessments were used to confirm that the depth of sedation met the goals of sedation, reduced anxiety, and awareness.
Follow-up patient assessments were conducted in a telephone interview 24 hours following treatment and during a clinic visit 2 to 5 days following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fospropofol disodium | Drug | – |
Primary outcome
Demonstrate that AQUAVAN was effective in providing adequate sedation in patients undergoing percutaneous coronary (PC) procedures.
1 secondary outcome
Treatment-emergent adverse events, Sedation-related adverse events, and airway Assistance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Jones, MD,PharmD study director
Eisai Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fospropofol disodium in people with Angioplasty and Coronary Catheterization, run by Eisai Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate that AQUAVAN was effective in providing adequate sedation in patients undergoing percutaneous coronary (PC) procedures.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2008; AzTrials last refreshed its copy on 7 Nov 2026.