Attention Deficit Hyperactivity Disorder (ADHD)Phase 3NCT01500694
Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe
A Phase 3 study testing Extended-release Guanfacine HCl (Intuniv, SPD503) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 60 sites in 13 countries.
Trial summary
For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Extended-release Guanfacine HCl (Intuniv, SPD503)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 60 sitesin 13 countries
- Study dates
- 20 Mar 2012to 15 Sep 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects where Study SPD503-318 was not available at the time of their final visit in the antecedent study (SPD503-315 or SPD503-316), may still be screened unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent/caregiver is satisfied with their current ADHD medication.
- Subject satisfied all entry criteria for the antecedent study (SPD503 315 or SPD503-316).
- Subject who is a female of child-bearing potential (FOCP), defined as >9 years of age or <9 years of age and is post-menarchal, must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol.
- Subject's parent or legally authorised representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
- Subject and parent/LAR are willing, able, and likely to fully comply with all the testing and requirements defined in this protocol, including oversight of dosing. Specifically, the parent/LAR must be available upon awakening, to dispense the dose of investigational product for the duration of the study.
- Subject has a supine and standing blood pressure (BP) measurement within the 95th percentile for age, sex, and height.
- Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator.
- Subject is able to swallow intact tablets.
Who cannot join
- Subject has any current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis (except oppositional defiant disorder), including any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis or conduct disorder that, in the opinion of the Investigator, contraindicate treatment with SPD503 or confound efficacy or safety assessments. The Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL) rating from the antecedent study should be reviewed to confirm diagnosis, if necessary.
- Subject who early terminated from Study SPD503-315 or Study SPD503-316 for protocol non-adherence, subject non-compliance, an AE, SAE, or withdrawal by subject.
- Subject experienced any clinically significant AE in their prior SPD503 study (SPD503-315 or SPD503 316) that, in the opinion of the Investigator, would preclude exposure to SPD503.
- Clinically important abnormality on urine drug and/or alcohol screen at the Screening Visit (Visit 1).
- Subject has taken any investigational product as follows: last dose of investigational product in Study SPD503-315 within 7 days prior to the Baseline Visit (Visit 2); investigational product in Study SPD503 316 within 30 days prior to the Baseline Visit (Visit 2); any other investigational product within 30 days prior to the Baseline Visit (Visit 2) or any other ADHD medication within 30 days prior to Baseline Visit (Visit 2).
- Subject is significantly overweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age sex-specific charts at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >95th percentile.
Show all 19Show fewer
- Children aged 6 12 years with a body weight of less than 25.0kg or adolescents aged 13 years and older with a body weight of less than 34.0kg at the Screening Visit (Visit 1).
- Subject has any condition or illness including clinically significant abnormal laboratory values at the Screening Visit (Visit 1) which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
- Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
- Subject has clinically significant ECG findings, as judged by the Investigator with consideration of the central ECG laboratory's interpretation, at the Baseline Visit (Visit 2).
- Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, or any components found in SPD503.
- Subject has a history of alcohol or other substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text RevisionÒ (DSM-IV-TRÒ; with the exception of nicotine) within the last 6 months.
- Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years) or the presence of a serious tic disorder including Tourette's syndrome.
- Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (eg, clinically significant heart block), exercise related cardiac events including syncope and pre syncope, or clinically significant bradycardia.
- Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
- Current use of any prohibited medication or other medications, including herbal supplements, that affect BP or heart rate or that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (ie, antihistamines) in violation of the protocol specified washout criteria at the Baseline Visit (Visit 2).
- Subject has a medical condition, other than ADHD, that requires treatment with medications that have CNS effects and/or affect performance.
- Subject is female and is pregnant or currently lactating.
- Subject failed screening or was previously enrolled in this study.
Trial locations and contacts
60 sites in 13 countries.
60 sites in 13 countries
Germany13 sites
Dr. med. Andreas Mahler
Achim, 28632
Emovis GmbH
Berlin, 10629
Sozialpsychitrisches Zentrum
Dorsten, 46282
Klinik und Poliklinik fur Kinder-und Jugendpsychiatrie un psychotherapie
Dresden, 01307
Dr. med Walter Robert Otto
Fulda, 36037
Dr. med. Christian Wolff
Hagen, 58093
Dr. med Friedrich Kaiser
Hamburg, 22415
Institut fur Ganzheitliche Medizin und Wissenschaft GmbH
Hüttenberg, 35625
Friedrich Schiller Universitat Jena Klinik fur Kinder und Jugendpsychiatrie
Jena, 07743
Universitatsmedizin der Johannes-Gutenberg-Universitat
Mainz, 55131
Kinder-und Jugendpsychiatrische Praxis
München, 81241
Somni bene GmbH Institut fur Medizinische Forschung und Schlatmedizin
Schwerin, 19053
Universitatsklinik Ulm
Ulm, 89075
Spain7 sites
Hospital Universitani Vall d'Hebron
Barcelona, 08035
Hospital Infanta Leonor, Servicio de Psiquiatria
Madrid, 28031
Hospital Fundacion Alcorcon
Madrid, 28922
Hospital Son Llatzer
Palma de Mallorca, 07198
Unidad de Salud Mental Infanto Juvenil
Santander, 39011
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221
Instituto Valenciano de Neurologia Pediatrica
Valencia, 46010
Ukraine7 sites
Regional Clinical Psychiatric Hospital
Donetsk, 83008
Institute of Neurology, Psychiatry and Narcology
Kharkiv, 61068
Institute of Health Care for Children and Teenagers
Kharkiv
Lviv Regional Clinical Psychiatric Hospital
Lviv, 79021
Odesa Regional Psychoneurological Dispensary
Odesa, 65084
Poltava Regional Clinical Psychiatric Hospital
Poltava, 36013
Vinnitsya regional psychoneurological hospital
Vinnytsia, 21005
Italy6 sites
Azienda Ospedaliero-Universitaria Policlinico-Vittorio
Catania, 95123
Azienda Ospedallera G Salvini - Ospedale Di Circolo de RHO
Milan, 20017
Azienda Ospedallera Fatebenefratelli
Milan, 20129
U.O di Neuropsichiatria Infantile
Padova, 35143
IRCCS Fondazione Stella Maris
Pisa, 56018
Ospedale Policlinico GB Rossi
Verona, 37134
United Kingdom6 sites
The Children's Centre
Norwich, NR4 7PA
Ryegate Children's Centre
Sheffield, S10 5DD
Centenary House Child and Adolescent Mental Health Services
Sheffield, S6 3BR
Lister Hospital
Stevenage, Herfordshire
Queen Elizabeth II Hospital - Howlands
Welwyn Garden City, Herfordshire, AL7 4HQ
Alder Hey Children's NHS Foundation Trust
West Derby, Liverpool, L12 2AP
Poland5 sites
NZOZ Gdanskie Centrum Zdrowia
Gdansk, 80-542
Centrum Badari Klinicznych House Sp. z.o.o.
Gdansk, 80-546
Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy
Torun, 87-100
Indywidualna Specjalisyczna Praktyka Lekarska
Torun, 87-100
Contrum Neurospychiatrii Neuromed
Wroclaw, 54-2353
Belgium4 sites
Universitaire Kinder-end Jeugdpsychatrie
Hoboken, 2660
Centre de Reference Neuropediatrique Multidisciplinaire
Namur, 5000
Huisartspraktijk Jaak Mortelmans
Oostham, 3845
Zlekenhuis Inkendaal Koninklijke Instelling v.z.w.
Vlezenbeek, 1602
France3 sites
Centre Hospitalier Universitaire Amiens
Amiens, Picardie, 80054
Centre Hospitalier Charles Perrens
Bordeaux, 33076
Hopital Gui de Chauliac
Montpellier, 34295
Romania3 sites
Spitalul Clinic de Psihiatrie
Bucharest, 041914
Spitalul Clinic de Psihiatrie Socoia
Iași, 700282
Spitalul Clinic de Urgenta pentru Copli
Timișoara, Timiș County, 300239
Austria2 sites
Medizinische Universitat Graz Univ fur Kinder
Graz, 6036
Institut fur Psychosomatik
Vienna, 1010
Netherlands2 sites
Flevo Research
Almere Stad, 1311 RL
Mondriaan Zorggroep
Heerlen, 6419 XZ
About this study
Official title: A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316
For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).
- Being tested
- Extended-release Guanfacine HCl (Intuniv, SPD503)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-release Guanfacine HCl (Intuniv, SPD503)Drug
Also called Intuniv, SPD503
Subjects will be dosed orally once-daily in the AM at 1, 2, 3, 4, 5, 6, or 7 mg according to subjects weight and age
| Study group | Role | What they receive |
|---|---|---|
| Extended-release Guanfacine HCl | Experimental | Not described Receives: Drug: Extended-release Guanfacine HCl (Intuniv, SPD503) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Systolic Blood Pressure at Final Assessment
Systolic Blood pressure was measured at supine and standing position and mean supine systolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication [Visit 19/Early Termination (ET)/Day 714].
Measured: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)
Change From Baseline in Mean Diastolic Blood Pressure at Final Assessment
Diastolic Blood pressure was measured at supine and standing position and mean supine diastolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Measured: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)
Change From Baseline in Mean Supine Pulse at Final Assessment
Pulse was measured at supine and standing position and mean supine pulse was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Measured: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)
Change From Baseline in Mean Height at Final Assessment
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Measured: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)
Change From Baseline in Mean Weight at Final Assessment
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Measured: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)
Change From Baseline in Electrocardiogram Result (QRS Interval) at Final Assessment
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Measured: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)
Change From Baseline in Electrocardiogram Result (QT Interval) at Final Assessment
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Measured: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)
Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
Measured: Final Assessment (last non missing data/up to Day 714)
Secondary outcomes (2)
Change From Baseline in Attention-deficit and Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) - Total Score at Final Assessment
ADHD-RS-IV was developed to measure the behaviours of children with ADHD with 18 items. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17) with possible score range from 0 (no symptoms) to 27 (most severe symptoms). The ADHD-RS-IV possible total scores range from 0 (no symptoms) to 54 (most severe symptoms). Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Measured: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)
Number of Participants Assessed With Clinical Global Impression Severity of Illness (CGI-S) Scale
The CGI-S evaluate each participant's severity and improvement over time. The severity of a participant's condition is rated on a 7-point scale ranging from 1 to 7. The scale measures 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill (BL-MI), 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill participant. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Measured: Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study start20 Mar 2012
- Primary completion15 Sep 2015
- Study completion15 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500694
- Sponsor's protocol ID
- SPD503-318
- Other IDs
- 2011-004668-31
- Status last verified
- May 2021
- First submitted
- 22 Dec 2011
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Huss M, Dirks B, Gu J, Robertson B, Newcorn JH, Ramos-Quiroga JA. Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD. Eur Child Adolesc Psychiatry. 2018 Oct;27(10):1283-1294. doi: 10.1007/s00787-018-1113-4. Epub 2018 Feb 13.
PubMed 29442229
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316
- ClinicalTrials.gov ID
- NCT01500694
- Acronym / sponsor ID
- SPD503-318
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2012 (actual)
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 15 Sep 2015 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended-release Guanfacine HCl | Experimental | Drug: Extended-release Guanfacine HCl (Intuniv, SPD503) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subjects where Study SPD503-318 was not available at the time of their final visit in the antecedent study (SPD503-315 or SPD503-316), may still be screened unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent/caregiver is satisfied with their current ADHD medication.
- Subject satisfied all entry criteria for the antecedent study (SPD503 315 or SPD503-316).
- Subject who is a female of child-bearing potential (FOCP), defined as >9 years of age or <9 years of age and is post-menarchal, must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol.
- Subject's parent or legally authorised representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
- Subject and parent/LAR are willing, able, and likely to fully comply with all the testing and requirements defined in this protocol, including oversight of dosing. Specifically, the parent/LAR must be available upon awakening, to dispense the dose of investigational product for the duration of the study.
Key exclusion criteria (19 listed)
- Subject has any current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis (except oppositional defiant disorder), including any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis or conduct disorder that, in the opinion of the Investigator, contraindicate treatment with SPD503 or confound efficacy or safety assessments. The Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL) rating from the antecedent study should be reviewed to confirm diagnosis, if necessary.
- Subject who early terminated from Study SPD503-315 or Study SPD503-316 for protocol non-adherence, subject non-compliance, an AE, SAE, or withdrawal by subject.
- Subject experienced any clinically significant AE in their prior SPD503 study (SPD503-315 or SPD503 316) that, in the opinion of the Investigator, would preclude exposure to SPD503.
- Clinically important abnormality on urine drug and/or alcohol screen at the Screening Visit (Visit 1).
- Subject has taken any investigational product as follows: last dose of investigational product in Study SPD503-315 within 7 days prior to the Baseline Visit (Visit 2); investigational product in Study SPD503 316 within 30 days prior to the Baseline Visit (Visit 2); any other investigational product within 30 days prior to the Baseline Visit (Visit 2) or any other ADHD medication within 30 days prior to Baseline Visit (Visit 2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended-release Guanfacine HCl (Intuniv, SPD503)Also: Intuniv, SPD503Subjects will be dosed orally once-daily in the AM at 1, 2, 3, 4, 5, 6, or 7 mg according to subjects weight and age | Drug | Extended-release Guanfacine HCl |
Primary outcome
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)
Systolic Blood pressure was measured at supine and standing position and mean supine systolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication [Visit 19/Early Termination (ET)/Day 714].
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)
Diastolic Blood pressure was measured at supine and standing position and mean supine diastolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
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)
Pulse was measured at supine and standing position and mean supine pulse was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
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)
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
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)
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
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)
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
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)
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
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)
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
2 secondary outcomes
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29442229Huss M, Dirks B, Gu J, Robertson B, Newcorn JH, Ramos-Quiroga JA. Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD. Eur Child Adolesc Psychiatry. 2018 Oct;27(10):1283-1294. doi: 10.1007/s00787-018-1113-4. Epub 2018 Feb 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
60 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extended-release Guanfacine HCl (Intuniv, SPD503) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 60 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Germany, Spain, Ukraine, Italy, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01500694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.