Phase 2
Completed N=10
Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure
Source: ClinicalTrials.gov NCT01297335 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Change in Blood Pressure After Intrathecal Injection of Clonidine. — 79; 37 mm Hg
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.
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 | — |
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
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. Informational only — not medical advice.