Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery
This study has been completed.
Sponsor:
The Medicines Company
Information provided by:
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00093262
First received: October 5, 2004
Last updated: October 29, 2008
Last verified: October 2008
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Purpose
The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating postoperative hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Clevidipine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery (ESCAPE-2) |
Resource links provided by NLM:
Further study details as provided by The Medicines Company:
Primary Outcome Measures:
- Incidence of bailout during 30-minute treatment period.
Secondary Outcome Measures:
- During the 30-minute treatment period: time to SBP reduction by 15% or more; mean
- arterial pressure change from baseline; heart rate change from baseline; incidence of bailout by causality.
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | October 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093262
Locations
| United States, Alabama | |
| Discovery Alliance - Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36602 | |
| United States, California | |
| Keck School of Medicine, University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| Huntington Memorial Hospital | |
| Pasadena, California, United States, 91109 | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305-5640 | |
| United States, Georgia | |
| Emory Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Heart Care Research Foundation | |
| Blue Island, Illinois, United States, 60406 | |
| MacNeal Hospital | |
| Glencoe, Illinois, United States, 60022 | |
| United States, Kansas | |
| Wesley Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Missouri | |
| St. Lukes Hospital | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Montana | |
| International Heart Institute | |
| Missoula, Montana, United States, 59802 | |
| United States, New York | |
| Mt. Sinai Medical Center | |
| New York, New York, United States, 10029-6574 | |
| Columbia University - College of Physicians and Surgeons | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Texas | |
| Discovery Alliance - Methodist Hospital / Diagnostic West Pavillion | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Medical College of Wisconsin VAMC - Milwaukee | |
| Milwaukee, Wisconsin, United States, 53295 | |
Sponsors and Collaborators
The Medicines Company
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00093262 History of Changes |
| Other Study ID Numbers: | TMC-CLV-03-02, ESCAPE-2 |
| Study First Received: | October 5, 2004 |
| Last Updated: | October 29, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The Medicines Company:
|
Post-operative Hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013