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Trial record 6 of 306 for:    Clonidine

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

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ClinicalTrials.gov Identifier: NCT01297335
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : January 1, 2016
Last Update Posted : October 19, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
The Center for Clinical Research, Winston-Salem, NC

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Drug: clonidine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intrathecal Clonidine

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.

clonidine: Intrathecal Clonidine


Participant Flow:   Overall Study
    Intrathecal Clonidine
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intrathecal Clonidine All subjects met all inclusion and exclusionary criteria, and we report study subjects' demographic information in following sections.

Baseline Measures
   Intrathecal Clonidine 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (5) 
Gender 
[Units: Participants]
 
Female   8 
Male   2 
Race/Ethnicity, Customized 
[Units: Participants]
 
African American, Non-hispanic   7 
White, Non-hispanic   3 
Region of Enrollment 
[Units: Participants]
 
United States   10 
Duration of Hypertension Diagnosis 
[Units: Years]
Mean (Full Range)
 17 
 (6 to 25) 
Number of active antihypertensive medications 
[Units: Participants]
 
4 active antihypertensive medications   8 
3 active antihypertensive medications   2 


  Outcome Measures

1.  Primary:   Change in Blood Pressure After Intrathecal Injection of Clonidine.   [ Time Frame: Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection ]

2.  Secondary:   Likert Scale Pain Rating   [ Time Frame: Pre-dose and 1 hour post injection. ]

3.  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   [ Time Frame: Before clonidine injection (Baseline), and at 1 hour after clonidine injection. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was limited by small sample size, and lack of control group.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: The Center for Clinical Research
phone: 3367656181
e-mail: rrauck@ccrpain.com


Publications:


Responsible Party: The Center for Clinical Research, Winston-Salem, NC
ClinicalTrials.gov Identifier: NCT01297335     History of Changes
Other Study ID Numbers: 1461 Clonidine
1461 ( Other Grant/Funding Number: Medtronic )
First Submitted: February 14, 2011
First Posted: February 16, 2011
Results First Submitted: July 27, 2015
Results First Posted: January 1, 2016
Last Update Posted: October 19, 2016