Phase 2 N=10 Treatment

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01297335 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2016

Primary outcome: Primary: Change in Blood Pressure After Intrathecal Injection of Clonidine. — 79; 37 mm Hg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: clonidine (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: The Center for Clinical Research, Winston-Salem, NC
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Blood Pressure After Intrathecal Injection of Clonidine.	79; 37	—
SECONDARY Likert Scale Pain Rating	6.5; 3.6	—
SECONDARY Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection	3.36; 3.47	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01297335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.