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Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
The Center for Clinical Research, Winston-Salem, NC
ClinicalTrials.gov Identifier:
NCT01297335
First received: February 14, 2011
Last updated: October 10, 2014
Last verified: August 2013
  Purpose

The purpose of this study is to determine the acute efficacy of intrathecal clonidine to reduce blood pressure in hypertensive subjects with poor blood pressure control and describe its effects on cardiovascular function.


Condition Intervention Phase
Hypertension
Drug: clonidine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemodynamic Effect of Intrathecal Clonidine in Hypertensive Subjects: A Pilot Study to Assess Its Effectiveness in Hypertensive Subjects With Poor Blood Pressure Control (Phase II)

Resource links provided by NLM:


Further study details as provided by The Center for Clinical Research, Winston-Salem, NC:

Primary Outcome Measures:
  • Decrease in Mean Arterial Blood Pressure of 15 mm Hg [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
    10 subjects with a decrease in Mean Arterial Blood Pressure of 15 mm Hg which is the minimal decrease that will be used to determine clinical significance.


Secondary Outcome Measures:
  • Intrathecal Clonidine Response Characterization #1 [ Time Frame: Pre-dose and 1 hour intervals ] [ Designated as safety issue: No ]

    Measured By:

    - One-minute isometric grip challenge


  • Intrathecal Clonidine Response Characterization #2 [ Time Frame: Pre-dose and 1 hour intervals ] [ Designated as safety issue: No ]

    Measured By:

    - Numeric Pain Score on 11-point Likert Scale


  • Intrathecal Clonidine Response Characterization #3 [ Time Frame: Pre-dose and 1 hour intervals ] [ Designated as safety issue: No ]

    Measured By:

    - Level of sedation and dry mouth on 10 cm visual analog scale (VAS)



Enrollment: 10
Study Start Date: February 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intrathecal Clonidine
Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
Drug: clonidine
Intrathecal Clonidine
Other Name: catapres

Detailed Description:

Hypertension occurs commonly, is associated with major morbidity and mortality, and responds poorly to current therapies in a small minority of compliant patients. The goal of this investigator-initiated study is to determine whether intrathecal administration of clonidine reduces blood pressure in hypertensive patients, focusing on a group who often achieve inadequate blood pressure control with multiple drug therapy.

After consent, pts will be screened and if qualified brought into center and intrathecal injection of clonidine given. Patients will be closely monitored for 4 hours, while data is collected.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of Hypertension
  • Stable systolic blood pressure >140 mmHg and < 190 mmHg
  • On 3 or more antihypertensive medications
  • On a diuretic
  • Patients must be able to understand the risks

Exclusion Criteria:

  • Allergy to clonidine
  • Presently on clonidine orally or transdermally
  • Known or suspected correctable causes of secondary hypertension
  • Breast Feeding or Pregnant women
  • Unstable Ischemic Heart Disease
  • Unstable Angina
  • Intracoronary Stent Placement
  • Coronary bypass within last 6 months
  • Myocardial Infarction within last 6 months
  • Congestive Failure
  • Cardiac Arrhythmias
  • Known Cerebral Vascular Disease
  • Renal Disease
  • Evidence of Injection Site Infection
  • Known Bleeding Disorders
  • Hepatic Insufficiency
  • Renal Insufficiency
  • Participation in an investigational drug study within 30 day of enrollment
  • Prohibited Medications:

    • Clonidine
    • Yohimbine
    • Tricyclic Antidepressants
    • Mirtazapine
    • Digitalis
    • Reserpine
    • Guanethidine
    • Non-Steroidal Anti-inflammatory Medication
    • Alcohol or Barbiturates within 48 hours of study procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297335

Sponsors and Collaborators
The Center for Clinical Research, Winston-Salem, NC
Medtronic
Investigators
Principal Investigator: Richard L. Rauck, MD Owner
  More Information

No publications provided

Responsible Party: The Center for Clinical Research, Winston-Salem, NC
ClinicalTrials.gov Identifier: NCT01297335     History of Changes
Other Study ID Numbers: 1461 Clonidine, 1461
Study First Received: February 14, 2011
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Center for Clinical Research, Winston-Salem, NC:
intrathecal
clonidine
poorly
controlled
hypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Clonidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014