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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: November 30, 2015
Last verified: November 2015
  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:
  • Change in Blood Pressure After Intrathecal Injection of Clonidine. [ Time Frame: Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection ] [ Designated as safety issue: No ]

    Subjects baseline blood pressure (systolic blood pressure (SBP), and diastolic blood pressure (DBP)), and blood pressures after clonidine injection was compared against baseline to assess efficacy of clonidine in refractory hypertensive subjects. Subject's blood pressure was monitored continuously after intrathecal injection of clonidine until subjects blood pressure nadir and return to pre clonidine injection level. The mean value reported below are the average changes in blood pressure from baseline (pre clonidine injection) in both SBP and DBP during post clonidine injection blood pressure monitoring for 4 hours.

    Blood pressure measurements were collected every 10 minutes for first hour after injection, and every 15 minutes after the first hour, up to 4 hours were averaged to report the change from baseline.



Secondary Outcome Measures:
  • Likert Scale Pain Rating [ Time Frame: Pre-dose and 1 hour post injection. ] [ Designated as safety issue: No ]
    Likert scale is 11 point digital pain rating system that asks subjects to rate their pain from 0 to 10. Rating of 0 means no pain at all, and in increasing order, 10 would mean worst pain imaginable/ unbearable pain.

  • Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection [ Time Frame: Before clonidine injection (Baseline), and at 1 hour after clonidine injection. ] [ Designated as safety issue: No ]
    Subjects were asked to rate severity of two of the most common side effects of clonidine, sedation and sensation of dry mouth, at pre and post (1 hour after) intrathecal administration of clonidine. The mean changes between pre and post injection VAS ratings of sedation and sensation of dry mouth are reported below. The VAS scale ranges from 1 to 10 cm, with higher values indicating higher level of sedation and higher level of dry mouth.


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   (Adult, Senior)
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

Publications:

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
Results First Received: July 27, 2015
Last Updated: November 30, 2015
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
Vascular Diseases
Cardiovascular Diseases
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016