HypertensionPhase 3ECLIPSE-NTGNCT00093886
Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)
A Phase 3 study testing clevidipine and nitroglycerin in people with Hypertension, run by The Medicines Company at 28 sites in United States.
Trial summary
The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 500-900 patients with perioperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- clevidipine and nitroglycerin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- 28 sitesUnited States
- Study dates
- Apr 2004to Apr 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
Prerandomization Inclusion Criteria:
- Provide written informed consent before initiation of any study related procedures.
- Be at least 18 years of age
- Be scheduled for Coronary Artery Bypass Grafting (CABG), Off Pump Coronary Artery Bypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery, and/or valve replacement/repair surgery
Prerandomization Exclusion Criteria:
- Women of child-bearing potential (unless they have a negative pregnancy test)
- Recent cerebrovascular accident (within 3 months before randomization)
- Known intolerance to calcium channel blockers
- Known or suspected hypersensitivity to nitroglycerin
- Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
- Pre-existing permanent ventricular pacing
- Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
- Participation in another therapeutic drug or therapeutic device trial within 30 days of starting study
Postrandomization Inclusion Criteria:
- Determined to be hypertensive perioperatively as determined by the investigator
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Brookwood Medical Center
Birmingham, Alabama, 35209
Baptist Medical Center, Montclair
Birmingham, Alabama, 35213
Medical Center East
Birmingham, Alabama, 35235
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45219
The Christ Hospital, The Linder Clinical Trial Center
Cincinnati, Ohio, 45219
Henry Ford Health System
Detroit, Michigan, 48202
Saint Francis Hospital
Evanston, Illinois, 60202
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96817
Memorial Herman Memorial City Hospital
Houston, Texas, 77024
Michael E DeBakey VA Medical Center
Houston, Texas, 77030-4211
The Methodist Hospital
Houston, Texas, 77030
Houston Northwest Medical Center
Houston, Texas, 77090
Regional Medical Center - Bayonet Point
Hudson, Florida, 34667
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Keck School of Medicine, University of Southern California
Los Angeles, California, 90033
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901
Baptist Medical Center, South
Montgomery, Alabama, 36116
New York University Medical Center
New York, New York, 10016
Huntington Memorial Hospital
Pasadena, California, 91109
Sacred Heart Health System
Pensacola, Florida, 32504
Portland VA Medical Center
Portland, Oregon, 97239
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
University of California
San Francisco, California, 94143-0648
Saint Joseph Medical Center
Tacoma, Washington, 98405
St Joseph Medical Center
Towson, Maryland, 21204
University Medical Center
Tucson, Arizona, 85724
Wesley Medical Center
Wichita, Kansas, 67214
About this study
Official title: Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)
The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 500-900 patients with perioperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nitroglycerin.
Read the detailed description
The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nitroglycerin treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect, and additional safety variables.
- Conditions
- Hypertension
- Being tested
- clevidipine, nitroglycerin
- Keywords
- Preoperative hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clevidipineDrug
Also called clevidipine, Cleviprex
nitroglycerinDrug
| Study group | Role | What they receive |
|---|---|---|
| clevidipine | Experimental | Clevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously (IV) at an initial infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/h). Clevidipine was titrated to blood pressure lowering effect by doubling increments approximately every 90 seconds up to a maximum infusion rate of 3.2 μg/kg/min (16 mg/h). Infusion rates above 3.2 μg/kg/min were permitted up to the maximum infusion rate of 8.0 μg/kg/min. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU. Infusion rates between 4.4 and 8.0 μg/kg/min were to be administered for no more than 2 hours. Receives: Drug: clevidipine |
| nitroglycerin | Active comparator | Nitroglycerin (NTG) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously as per institutional practice. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU. Receives: Drug: nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of death, stroke, MI and renal dysfunction
Measured: Initiation of study drug infusion through post-operative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2004 (estimated)
- Study startApr 2004
- Primary completionMar 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Malcolm Lloyd, MD, Study director, The Medicines Company - Medical Director, Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093886
- Sponsor's protocol ID
- TMC-CLV-03-03
- Acronym
- ECLIPSE-NTG
- Status last verified
- May 2014
- First submitted
- 7 Oct 2004
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.
PubMed 18806012
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events (With Nitroglycerin as Active Comparator) (ECLIPSE-NTG)
- ClinicalTrials.gov ID
- NCT00093886
- Acronym / sponsor ID
- ECLIPSE-NTG / TMC-CLV-03-03
- Conditions
- Hypertension
- Keywords
- Preoperative hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 8 Oct 2004 (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 purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 500-900 patients with perioperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nitroglycerin.
Detailed description
The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nitroglycerin treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect, and additional safety variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clevidipine | Experimental | Drug: clevidipineClevidipine (0.5 mg/mL in 20% lipid emulsion) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously (IV) at an initial infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/h). Clevidipine was titrated to blood pressure lowering effect by doubling increments approximately every 90 seconds up to a maximum infusion rate of 3.2 μg/kg/min (16 mg/h). Infusion rates above 3.2 μg/kg/min were permitted up to the maximum infusion rate of 8.0 μg/kg/min. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU. Infusion rates between 4.4 and 8.0 μg/kg/min were to be administered for no more than 2 hours. |
| nitroglycerin | Active comparator | Drug: nitroglycerinNitroglycerin (NTG) was initiated after insertion of an arterial line upon the occurrence of perioperative hypertension, as determined by the investigator, and was administered intravenously as per institutional practice. Treatment was maintained as long as was deemed clinically necessary or until discharge from the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| clevidipineAlso: clevidipine, Cleviprex | Drug | clevidipine |
| nitroglycerin | Drug | nitroglycerin |
Primary outcome
Incidence of death, stroke, MI and renal dysfunction
Time frame: Initiation of study drug infusion through post-operative Day 30
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 6 May 2014.
- Results publication: PubMed 18806012Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.
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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.
Malcolm Lloyd, MD study director
The Medicines Company - Medical Director, Clinical Operations
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clevidipine and nitroglycerin in people with Hypertension, run by The Medicines Company at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Incidence of death, stroke, MI and renal dysfunction (time frame: Initiation of study drug infusion through post-operative Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00093886, which also lists 1 linked publication.
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 6 May 2014.