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clonidine · 1 trial · 1 indication
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...
Clonidine is a small molecule being studied for the treatment of hypertension, specifically in subjects with poorly controlled blood pressure. It is administered intrathecally and is currently in Phase 2 clinical development as an investigational therapy.
Clonidine is an alpha-2 adrenergic agonist, meaning it works by stimulating alpha-2 adrenergic receptors in the brain. This action reduces sympathetic outflow from the central nervous system, which can lower blood pressure. It is being evaluated for its effect on blood pressure control in hypertensive patients.
Clonidine is being developed by Medtronic plc, a medical device company traded on the New York Stock Exchange under the ticker symbol MDT. The company is conducting clinical research to evaluate the drug's potential in treating hypertension.
Clonidine is in Phase 2 clinical development for hypertension. It is an investigational drug and has not been approved by regulatory authorities for this use. The Phase 2 trial has been completed, and the drug remains under evaluation for its safety and efficacy.
Clonidine has one completed Phase 2 clinical trial registered under NCT01297335, titled 'Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure.' The trial enrolled 10 participants and was not randomized, double-blind, or controlled, but it did use a biomarker-selected approach.
Clonidine is the generic name for the drug also known as Catapres, which is an oral medication used to treat high blood pressure. However, the product under investigation here is an intrathecal formulation of clonidine, which is administered via injection into the spinal fluid, and it is being developed by Medtronic for hypertension.