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Generated: September 18, 2019

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CLINICAL TRIALS PROFILE FOR CATAPRES

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Clinical Trials for Catapres

Trial ID Title Status Sponsor Phase Summary
NCT00329511 A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy Terminated University of California, Irvine N/A High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk of development of pregnancy related high BP called preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature separation of the placenta from the uterus resulting in damage to the fetus and cesarean delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes, and therefore, medications to lower BP are used for moderate to severe hypertension. To date the literature on the medications used in pregnancy is extremely limited. Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak antihypertensive medicine given three or four times a day and frequently needs changes in the dose or may require an additional medication to control BP. This may lead to a greater chance of non compliance. Another option is Clonidine which is an effective antihypertensive treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects. Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period. The study will determine differences in compliance between the two antihypertensive regimens- oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and adequacy of BP control, as well as provide information on an alternate option for BP control.
NCT01139996 Use of Transdermal Clonidine in Trauma Patients Completed Memorial Health University Medical Center Phase 4 This study will attempt to learn how to better treat trauma patients with delirium who are on a breathing machine. Delirium, also known as acute, temporary brain dysfunction, is a common reason why ventilated patients can not be weaned from the breathing machine even though their lungs may be healthy enough to breathe without the machine. The study hopes to show that by decreasing the patient's delirium it will lead to quicker weaning from the breathing machine and possibly a quicker overall recovery as well. Patients enrolled in this study will be treated with Clonidine or placebo. Clonidine is a drug that produces significant calming effects, decreases anxiety, and reduces pain, but with a lower incidence of delirium than other medications used in the ICU for this purpose. Clonidine is not approved by the Federal Food and Drug Administration for treatment of delirium, but is commonly used for this purpose.
NCT01876355 The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients Not yet recruiting Deventer Ziekenhuis Phase 3 Rationale: Delirium is highly prevalent in the ICU. GABA-ergic anaesthetics may provoke delirium. Alpha-2-adrenergic agonists may lead to a reduction of the total amount of GABA-ergic anaesthetics and reduction of delirium. There are no large studies proving that this therapy is effective and safe. Objective: The objective of this study is to compare the effect of clonidine with placebo on the occurrence and duration of delirium in mechanically ventilated ICU patients. Study design: Prospective randomised double-blind placebo controlled intervention study in 115 patients. Study population: All patients >18 years old, intubated mechanically ventilated and sedated at inclusion. Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen. Comparison: NaCl 0,9 % infusion as placebo. Main study parameters/endpoints: The main study parameter is the total number of awake and delirium-free observation periods the first 7 days after randomisation. An observation period is a nursing shift of 8 hours.
NCT02548806 Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers Completed Simbec Research Phase 1 The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.
NCT02548806 Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers Completed Onxeo Phase 1 The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.
NCT02571283 Peri-articular Injection Utilizing a Pain Cocktail With and Without Exparel Withdrawn Arthroplasty Foundation, Inc. Phase 4 A prospective, randomized control study will be conducted to compare postoperative pain control in a series of patients treated with either: 1. a local cocktail. 2. a local cocktail plus Exparel. 3. marcaine plus Exparel prior to wound closure following knee arthroplasty.
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Clinical Trial Conditions for Catapres

Condition Name

Condition Name for Catapres
Intervention Trials
Delirium 2
Critical Illness 1
Total Knee Arthroplasty 1
Pain Management 1
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Condition MeSH

Condition MeSH for Catapres
Intervention Trials
Critical Illness 2
Delirium 2
Pre-Eclampsia 1
Hypertension, Pregnancy-Induced 1
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Clinical Trial Locations for Catapres

Trials by Country

Trials by Country for Catapres
Location Trials
United States 2
United Kingdom 2
Netherlands 1
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Trials by US State

Trials by US State for Catapres
Location Trials
Georgia 1
California 1
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Clinical Trial Progress for Catapres

Clinical Trial Phase

Clinical Trial Phase for Catapres
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Catapres
Clinical Trial Phase Trials
Completed 2
Withdrawn 1
Not yet recruiting 1
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Clinical Trial Sponsors for Catapres

Sponsor Name

Sponsor Name for Catapres
Sponsor Trials
University of Warwick 1
Onxeo 1
NHS Lothian 1
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Sponsor Type

Sponsor Type for Catapres
Sponsor Trials
Other 18
Industry 2
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