Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department

NCT00765648 | Completed Phase 4 Results DMC

• 1 other identifier: 2008-001
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol administered intravenously for the management of hypertension in the emergency department setting.

Conditions

Hypertensive Urgency

Keywords

hypertension; emergency department; Nicardipine; Labetalol; hypertensive emergency; hypertensive urgency

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.

  Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.

  30 minutes after initiation of therapy

Secondary Outcomes (5)

• Average Number of Dose Titrations Within 30 Minutes

  30 minutes

• Emergency Department(ED)Time to Disposition Decision

  6 hours

• Treatment Failure

  6 hours

• Subjects Requiring the Use of Intravenous Rescue Medications

  6 hours

• Transition Time to Oral Medication

  6 hours

Study Arms (2)

1

ACTIVE COMPARATOR

nicardipine intravenous

Drug: nicardipine intravenous

2

ACTIVE COMPARATOR

Labetalol

Drug: Labetalol

Interventions

nicardipine intravenous DRUG

nicardipine intravenous 5 mg/hour titrated every 5 minutes by 2.5 mg/hour until target systolic blood pressure range (TSBPR) is reached or maximum dose of 15 mg/hour is achieved.Following achievement of target systolic blood pressure range the infusion rate should be decreased to 3 mg/hour

Also known as: Nicardipine hydrochloride

1

Labetalol DRUG

Labetalol: bolus therapy to start at 20 mg intravenous injection over 2 minutes, may repeat 20mg, 40mg or 80mg injections every 10 minutes until target systolic blood pressure range(TSBPR)is reached or a maximum of 300 mg is injected.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Systolic blood pressure ≥180 mm Hg on 2 consecutive readings(10 minutes apart)presenting in the emergency department (ED)

You may not qualify if:

• Use of any investigational drug within 1 month prior to emergency department (ED)
• Pregnant or breast-feeding females
• Contraindications or allergy to beta-blockers and calcium channel blockers (see FDA approved labeling for nicardipine intravenous and labetalol)
• Subjects with decompensated congestive heart failure (CHF) or with a known left ventricular ejection fraction (LVEF) \<35%
• History of stroke within 30 days
• Known liver failure
• Suspected myocardial infarction
• Suspected aortic dissection
• Suspected cocaine overdose
• Concurrently receiving other intravenous (I.V.) hypertensive medications

Sponsors & Collaborators

• The Cleveland Clinic: lead
• EKR Therapeutics, Inc: collaborator

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44122, United States

Location

University of Texas Health Science Center

Houston, Texas, United States

Location

Related Publications (3)

• Varon J, Soto-Ruiz KM, Baumann BM, Borczuk P, Cannon CM, Chandra A, Cline DM, Diercks DB, Hiestand B, Hsu A, Jois-Bilowich P, Kaminski B, Levy P, Nowak RM, Schrock JW, Peacock WF. The management of acute hypertension in patients with renal dysfunction: labetalol or nicardipine? Postgrad Med. 2014 Jul;126(4):124-30. doi: 10.3810/pgm.2014.07.2790.

  PMID: 25141250 DERIVED

• Cannon CM, Levy P, Baumann BM, Borczuk P, Chandra A, Cline DM, Diercks DB, Hiestand B, Hsu A, Jois P, Kaminski B, Nowak RM, Schrock JW, Varon J, Peacock WF. Intravenous nicardipine and labetalol use in hypertensive patients with signs or symptoms suggestive of end-organ damage in the emergency department: a subgroup analysis of the CLUE trial. BMJ Open. 2013 Mar 26;3(3):e002338. doi: 10.1136/bmjopen-2012-002338.

  PMID: 23535700 DERIVED

• Peacock WF, Varon J, Baumann BM, Borczuk P, Cannon CM, Chandra A, Cline DM, Diercks D, Hiestand B, Hsu A, Jois-Bilowich P, Kaminski B, Levy P, Nowak RM, Schrock JW. CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department. Crit Care. 2011;15(3):R157. doi: 10.1186/cc10289. Epub 2011 Jun 27.

  PMID: 21707983 DERIVED

MeSH Terms

Conditions

Hypertensive Crisis; Hypertension; Emergencies

Interventions

Nicardipine; Labetalol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Results Point of Contact

• Title: Frank Peacock MD
• Organization: Cleveland Clinic

peacocw@ccf.org

(216) 445-4557

Study Officials

• W. Frank Peacock, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Joseph Varon, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 6, 2015
• Results First Posted: December 11, 2014

Record last verified: 2011-07

Locations

US (2)