HypertensionPhase 3ESCAPE-2NCT00093262

Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

A Phase 3 study testing clevidipine in people with Hypertension, run by The Medicines Company at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. Approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary… 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
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 206 participants
Where: 15 sitesUnited States
Study dates: Dec 2003to Oct 2004
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

Pre-randomization Inclusion Criteria:

Provide written informed consent before initiation of any study-related procedures.
Be at least 18 years of age
Be scheduled for cardiac surgery (including Coronary Artery Bypass Grafting [CABG], Off Pump Coronary Artery Bypass [OPCAB], Minimally Invasive Direct Coronary Artery Bypass [MIDCAB] surgery, and/or valve replacement/repair procedures)

Pre-randomization 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
Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
Pre-existing left bundle branch block or 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

Post-randomization Inclusion Criteria:

Expected to survive beyond 24 hours post-surgical procedure
No surgical complications or conditions, present or anticipated, that preclude them from inclusion in a double blind, placebo-controlled study
Determined to be hypertensive (SBP > 140 mm Hg) within 4 hours of arrival in a postoperative setting
It is the investigator's intent to lower the patient's SBP by a minimum of 15% from its baseline value

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Emory Hospital
Atlanta, Georgia, 30322
Heart Care Research Foundation
Blue Island, Illinois, 60406
Carolinas Medical Center
Charlotte, North Carolina, 28203
MacNeal Hospital
Glencoe, Illinois, 60022
Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion
Houston, Texas, 77030
St. Lukes Hospital
Kansas City, Missouri, 64111
Keck School of Medicine, University of Southern California
Los Angeles, California, 90033
Medical College of Wisconsin VAMC - Milwaukee
Milwaukee, Wisconsin, 53295
International Heart Institute
Missoula, Montana, 59802
Discovery Alliance - Mobile Infirmary Medical Center
Mobile, Alabama, 36602
Mt. Sinai Medical Center
New York, New York, 10029-6574
Columbia University - College of Physicians and Surgeons
New York, New York, 10032
Huntington Memorial Hospital
Pasadena, California, 91109
Stanford University School of Medicine
Stanford, California, 94305-5640
Wesley Medical Center
Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)

Read the detailed description

The primary objective was to determine the efficacy of clevidipine versus placebo in treating postoperative hypertension by comparing the incidence of bailout in the clevidipine and placebo treatment groups during the 30-minute time period from initiation of study drug. Secondary objectives included assessments of efficacy through measuring time to target blood pressure (BP) lowering effect defined as 15% reduction in SBP, change in mean arterial pressure (MAP) and the incidence of bailout by causality. Assessments for safety included change in heart rate (HR) from baseline.

Conditions: Hypertension
Being tested: clevidipine, placebo
Keywords: Postoperative 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
placeboDrug

Study groups in NCT00093262
Study group	Role	What they receive
clevidipine	Experimental	Clevidipine was administered in a blinded fashion intravenously, starting with an infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/hr), titrating upward, as tolerated by the patient, in doubling increments approximately every 90 seconds up to an infusion rate of 3.2 μg/kg/min (16 mg/hr) to achieve the desired blood pressure-lowering effect. Up-titration to infusion rates above 3.2 μg/kg/min could be used, guided by the patient's response, by increasing the infusion rate in serial increments of 1.5 μg/kg/min, up to the maximum recommended clevidipine infusion rate of 8.0 μg/kg/min. Clevidipine was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour. Receives: Drug: clevidipine
placebo	Placebo comparator	Placebo consisted of 20% lipid emulsion (the same lipid vehicle used for clevidipine) administered in a blinded fashion intravenously following the same study drug administration guidelines as with clevidipine study drug administration guidelines. As with clevidipine, placebo was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of bailout during 30-minute treatment period
The incidence of bailout defined as the premature and permanent discontinuation of study drug categorized according to the following reasons:
- Bailout for lack of efficacy
- Bailout for safety reason(s)
- Bailout due to treatment failure
Measured: During the first 30 minutes post study drug initiation

Secondary outcomes (4)

Median time to target SBP lowering effect (defined as a reduction by 15% or more)
Measured: During the first 30 minutes post study drug initiation
Mean arterial pressure (MAP) change from baseline
Measured: During the first 30 minutes post study drug initiation
Heart rate change from baseline
Measured: During the first 30 minutes post study drug initiation
Incidence of bailout by causality
Measured: During the first 30 minutes post study drug initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2003Oct 2004

First posted7 Oct 2004 (estimated)
Study startDec 2003
Primary completionOct 2004
Study completionOct 2004

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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00093262
Sponsor's protocol ID: TMC-CLV-03-02
Other IDs: ESCAPE-2
Acronym: ESCAPE-2
Status last verified: May 2014
First submitted: 5 Oct 2004
Last updated: 8 May 2014
Results posted: No
Data monitoring committee: Yes

Publications

Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Aronson S, Newman MF, Corwin HL; ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008 Jul;107(1):59-67. doi: 10.1213/ane.0b013e3181732e53.
PubMed 18635468

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2)
ClinicalTrials.gov ID: NCT00093262
Acronym / sponsor ID: ESCAPE-2 / TMC-CLV-03-02
Conditions: Hypertension
Keywords: Postoperative Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 206 participants (actual)
Lead sponsor: The Medicines CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2003
Primary completion: Oct 2004 (actual)
Study completion: Oct 2004 (actual)
First posted: 7 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
clevidipine	Experimental	Drug: clevidipineClevidipine was administered in a blinded fashion intravenously, starting with an infusion rate of 0.4 μg/kg/min (non weight-based equivalent is 2 mg/hr), titrating upward, as tolerated by the patient, in doubling increments approximately every 90 seconds up to an infusion rate of 3.2 μg/kg/min (16 mg/hr) to achieve the desired blood pressure-lowering effect. Up-titration to infusion rates above 3.2 μg/kg/min could be used, guided by the patient's response, by increasing the infusion rate in serial increments of 1.5 μg/kg/min, up to the maximum recommended clevidipine infusion rate of 8.0 μg/kg/min. Clevidipine was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.
placebo	Placebo comparator	Drug: placeboPlacebo consisted of 20% lipid emulsion (the same lipid vehicle used for clevidipine) administered in a blinded fashion intravenously following the same study drug administration guidelines as with clevidipine study drug administration guidelines. As with clevidipine, placebo was to be administered for a minimum of 30 minutes, unless bailout occurred, and up to a maximum of one hour.

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
placebo	Drug	placebo

Primary outcome

Incidence of bailout during 30-minute treatment period
Time frame: During the first 30 minutes post study drug initiation
The incidence of bailout defined as the premature and permanent discontinuation of study drug categorized according to the following reasons: * Bailout for lack of efficacy * Bailout for safety reason(s) * Bailout due to treatment failure

4 secondary outcomes

Median time to target SBP lowering effect (defined as a reduction by 15% or more)
Time frame: During the first 30 minutes post study drug initiation
Mean arterial pressure (MAP) change from baseline
Time frame: During the first 30 minutes post study drug initiation
Heart rate change from baseline
Time frame: During the first 30 minutes post study drug initiation
Incidence of bailout by causality
Time frame: During the first 30 minutes post study drug initiation

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 8 May 2014.
Results publication: PubMed 18635468Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Aronson S, Newman MF, Corwin HL; ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008 Jul;107(1):59-67. doi: 10.1213/ane.0b013e3181732e53.

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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

The record lists no contact. Use the official record to reach the sponsor.

15 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 in people with Hypertension, run by The Medicines Company at 15 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 8 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 15 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. Some participants in this study may receive a placebo. 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 bailout during 30-minute treatment period (time frame: During the first 30 minutes post study drug initiation). 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 NCT00093262, 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 8 May 2014.