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

Information source: The Center for Clinical Research, Winston-Salem, NC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: clonidine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: The Center for Clinical Research, Winston-Salem, NC

Official(s) and/or principal investigator(s):
Richard L. Rauck, MD, Principal Investigator, Affiliation: Owner


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.

Clinical Details

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)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Decrease in Mean Arterial Blood Pressure of 15 mm Hg

Secondary outcome:

Intrathecal Clonidine Response Characterization #1

Intrathecal Clonidine Response Characterization #2

Intrathecal Clonidine Response Characterization #3

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.


Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: February 2011
Last updated: October 10, 2014

Page last updated: August 20, 2015

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