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

T

The Center for Clinical Research, Winston-Salem, NC

Status and phase

Completed
Phase 2

Conditions

Hypertension

Treatments

Drug: clonidine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01297335
1461 Clonidine
1461 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

30 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Intrathecal Clonidine
Experimental group
Description:
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.
Treatment:
Drug: clonidine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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