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Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01500694
First Posted: December 28, 2011
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
Results First Submitted: July 22, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: ADHD
Intervention: Drug: Extended-release Guanfacine HCl (Intuniv, SPD503)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 52 sites in 11 countries in Europe: Austria, Belgium, France, Germany, Italy, The Netherlands, Poland, Romania, Spain, Ukraine, and United Kingdom.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall 218 participants screened, of them 215 were enrolled and 214 were treated in the study.The first participant’s consent was obtained on 20 March 2012 and last participant assessment took place on 15 September 2015.

Reporting Groups
  Description
SPD503 (6-12 Years) Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 milligram [mg] or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
SPD503 (13-18 Years) Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.

Participant Flow:   Overall Study
    SPD503 (6-12 Years)   SPD503 (13-18 Years)
STARTED   131   83 [1] 
COMPLETED   79   54 
NOT COMPLETED   52   29 
Adverse Event                4                3 
Protocol Violation                0                1 
Withdrawal by Subject                23                14 
Lost to Follow-up                2                3 
Lack of Efficacy                14                5 
Other                9                3 
[1] Participants who received treatment were reported as Started.



  Baseline Characteristics
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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.
Safety analysis set included all enrolled participants who took at least 1 dose of SPD503.

Reporting Groups
  Description
SPD503 (6-12 Years) Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
SPD503 (13-18 Years) Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
Total Total of all reporting groups

Baseline Measures
   SPD503 (6-12 Years)   SPD503 (13-18 Years)   Total 
Overall Participants Analyzed 
[Units: Participants]
 131   83   214 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.8  (1.56)   14.7  (1.49)   11.7  (2.82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      26  19.8%      30  36.1%      56  26.2% 
Male      105  80.2%      53  63.9%      158  73.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Mean Systolic Blood Pressure at Final Assessment   [ Time Frame: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) ]

2.  Primary:   Change From Baseline in Mean Diastolic Blood Pressure at Final Assessment   [ Time Frame: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) ]

3.  Primary:   Change From Baseline in Mean Supine Pulse at Final Assessment   [ Time Frame: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) ]

4.  Primary:   Change From Baseline in Mean Height at Final Assessment   [ Time Frame: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) ]

5.  Primary:   Change From Baseline in Mean Weight at Final Assessment   [ Time Frame: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) ]

6.  Primary:   Change From Baseline in Electrocardiogram Result (QRS Interval) at Final Assessment   [ Time Frame: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) ]

7.  Primary:   Change From Baseline in Electrocardiogram Result (QT Interval) at Final Assessment   [ Time Frame: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) ]

8.  Primary:   Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Final Assessment (last non missing data/up to Day 714) ]

9.  Secondary:   Change From Baseline in Attention-deficit and Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) - Total Score at Final Assessment   [ Time Frame: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) ]

10.  Secondary:   Number of Participants Assessed With Clinical Global Impression Severity of Illness (CGI-S) Scale   [ Time Frame: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire
phone: 1 866-842-5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01500694     History of Changes
Other Study ID Numbers: SPD503-318
2011-004668-31 ( EudraCT Number )
First Submitted: December 22, 2011
First Posted: December 28, 2011
Results First Submitted: July 22, 2016
Results First Posted: May 18, 2017
Last Update Posted: June 23, 2017