Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01297335 | Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure | PHASE2 | COMPLETED | 10 | — | — | Feb 1, 2011 | Jul 1, 2012 | Oct 19, 2016 | - | — |
Subjects baseline blood pressure (systolic blood pressure (SBP), and diastolic blood pressure (DBP)), and blood pressures after clonidine injection was compared against baseline to assess efficacy of clonidine in refractory hypertensive subjects. Subject's blood pressure was monitored continuously after intrathecal injection of clonidine until subjects blood pressure nadir and return to pre clonidine injection level. The mean value reported below are the average changes in blood pressure from baseline (pre clonidine injection) in both SBP and DBP during post clonidine injection blood pressure monitoring for 4 hours. Blood pressure measurements were collected every 10 minutes for first hour after injection, and every 15 minutes after the first hour, up to 4 hours were averaged to report the change from baseline.
| Arm | Type | Description |
|---|---|---|
| Intrathecal Clonidine | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| clonidine | DRUG | Intrathecal Clonidine |
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 tra...