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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Center for Clinical Research, Winston-Salem, NC
• Collaborator: Medtronic
• Treatments: Clonidine

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