Attention Deficit Hyperactivity DisorderPhase 3NCT00700427
A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 3 study testing atomoxetine hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 56 sites in 12 countries.
Trial summary
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- atomoxetine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,017 participants
- Where
- 56 sitesin 12 countries
- Study dates
- Jun 2008to Oct 2013
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults
- Male or female
- Must meet Attention-Deficit/Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™) criteria
Who cannot join
- Comorbidity with major psychiatric disorder
- Clinically significant depression or anxiety
- Patients with significant medical conditions
- Current alcohol/drugs abuse/dependence
- Concomitant excluded medications
Trial locations and contacts
56 sites in 12 countries.
56 sites in 12 countries
Germany18 sites
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Ahrensburg, 22926
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Berlin, D-14050
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Bochum, 44791
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Ellwangen, 73479
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Essen, D-45147
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Freiburg im Breisgau, 79104
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Fulda, 36037
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Hadamar, 65589
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Hagen, 58093
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Hamburg, 22527
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Hanover, 30625
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Homburg, 66421
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Leipzig, 04157
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Ludwigshafen, 67071
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Mainz, 55131
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Mannheim, 68159
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Munich, 80333
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Würzburg, 97070
France6 sites
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Bordeaux, 33076
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Douai, 59500
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Marseille, 13009
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Montpellier, 34295
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Nice, 06200
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Orvault, 44000
Belgium5 sites
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Bruges, 8310
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Kortenberg, 3070
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Liège, 4000
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Mechelen, 2800
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Uccle, 1180
Netherlands5 sites
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Amersfoort, 3816 CP
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Flushing, 4382 EE
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Hengelo, 7555 DL
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Nijmegen, 6500 HB
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Tilburg, 5037 SK
Spain5 sites
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Alcorcón, 28922
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Barcelona, 08035
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Madrid, 28002
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Pamplona, 31008
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Zamora, 49021
Sweden4 sites
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Luleå, SE 972 35
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Lund, 22361
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Malmö, 21135
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Vaxjo, SE 351 88
Finland3 sites
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Helsinki, 00029 HUS
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Tampere, 33100
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Turku, 20100
Italy3 sites
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Coppito, 67100
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Milan, 20121
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San Donà di Piave, 30027
United Kingdom3 sites
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Brighton, East Sussex, BN1 3RJ
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London, SE5 8AZ
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Storrington, West Sussex, RH20 4NQ
Portugal2 sites
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Cascais, 2750-782
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Coimbra, 3030
Austria1 site
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Vienna, A1090
Switzerland1 site
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Lausanne, 1005
About this study
Official title: Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- atomoxetine hydrochloride, Placebo
- Keywords
- ADHD, Adult, long term, maintenance of response, Attention Deficit Hyperactivity Disorder
- 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.
atomoxetine hydrochlorideDrug
Also called Strattera, LY139603, atomoxetine
Oral 40-100 mg/day
PlaceboDrug
Oral delivery of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine | Experimental | Atomoxetine 40-100 milligrams per day (mg/day) orally, once daily or twice daily for 24 weeks, followed by atomoxetine 80-100 mg/day orally, once daily or twice daily for 25 weeks. Receives: Drug: atomoxetine hydrochloride |
| Placebo | Placebo comparator | Atomoxetine 40-100 mg/day orally, once daily or twice daily for 24 weeks, followed by placebo orally, once daily for 25 weeks. Receives: Drug: atomoxetine hydrochloride; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period
Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.
Measured: Baseline (Week 24) up to Week 49
Secondary outcomes (7)
Number of Days Until Relapse
Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.
CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Measured: Baseline (Week 24) up to Week 49
Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49
The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.
Measured: Baseline (Week 24), Week 49
Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49
The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
Measured: Baseline (Week 24), Week 49
Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49
CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.
Measured: Baseline (Week 24), Week 49
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
Measured: Baseline (Week 24), Week 49
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
BRIEF-A:Informant is a 75-item third-party observer's view of the participants' executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.
Measured: Baseline (Week 24), Week 49
Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49
The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state "worse than dead." A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.
Measured: Baseline (Week 24), Week 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2011
- Study completionOct 2013
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 (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700427
- Sponsor's protocol ID
- 9655
- Other IDs
- B4Z-MC-LYDO
- Status last verified
- Jun 2014
- First submitted
- 16 Jun 2008
- Last updated
- 26 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tanaka Y, Escobar R, Upadhyaya HP. Assessment of effects of atomoxetine in adult patients with ADHD: consistency among three geographic regions in a response maintenance study. Atten Defic Hyperact Disord. 2017 Jun;9(2):113-120. doi: 10.1007/s12402-016-0212-7. Epub 2017 Jan 6.
PubMed 28058589Upadhyaya H, Tanaka Y, Lipsius S, Kryzhanovskaya LA, Lane JR, Escobar R, Trzepacz PT, Allen AJ. Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD. Postgrad Med. 2015;127(7):677-85. doi: 10.1080/00325481.2015.1083394. Epub 2015 Sep 2.
PubMed 26329980Upadhyaya H, Adler LA, Casas M, Kutzelnigg A, Williams D, Tanaka Y, Arsenault J, Escobar R, Allen AJ. Baseline characteristics of European and non-European adult patients with attention deficit hyperactivity disorder participating in a placebo-controlled, randomized treatment study with atomoxetine. Child Adolesc Psychiatry Ment Health. 2013 May 6;7(1):14. doi: 10.1186/1753-2000-7-14.
PubMed 23648011
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study
- ClinicalTrials.gov ID
- NCT00700427
- Acronym / sponsor ID
- 9655
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Adult, long term, maintenance of response, Attention Deficit Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,017 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Posted 29 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Experimental | Drug: atomoxetine hydrochlorideAtomoxetine 40-100 milligrams per day (mg/day) orally, once daily or twice daily for 24 weeks, followed by atomoxetine 80-100 mg/day orally, once daily or twice daily for 25 weeks. |
| Placebo | Placebo comparator | Drug: atomoxetine hydrochloride, Drug: PlaceboAtomoxetine 40-100 mg/day orally, once daily or twice daily for 24 weeks, followed by placebo orally, once daily for 25 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults
- Male or female
- Must meet Attention-Deficit/Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™) criteria
Key exclusion criteria (5 listed)
- Comorbidity with major psychiatric disorder
- Clinically significant depression or anxiety
- Patients with significant medical conditions
- Current alcohol/drugs abuse/dependence
- Concomitant excluded medications
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 |
|---|---|---|
| atomoxetine hydrochlorideAlso: Strattera, LY139603, atomoxetineOral 40-100 mg/day | Drug | Atomoxetine, Placebo |
| PlaceboOral delivery of matching placebo | Drug | Placebo |
Primary outcome
Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period
Time frame: Baseline (Week 24) up to Week 49
Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.
7 secondary outcomes
Number of Days Until Relapse
Time frame: Baseline (Week 24) up to Week 49
Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49
Time frame: Baseline (Week 24), Week 49
Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49
Time frame: Baseline (Week 24), Week 49
Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49
Time frame: Baseline (Week 24), Week 49
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
Time frame: Baseline (Week 24), Week 49
Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49
Time frame: Baseline (Week 24), Week 49
Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49
Time frame: Baseline (Week 24), Week 49
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28058589Tanaka Y, Escobar R, Upadhyaya HP. Assessment of effects of atomoxetine in adult patients with ADHD: consistency among three geographic regions in a response maintenance study. Atten Defic Hyperact Disord. 2017 Jun;9(2):113-120. doi: 10.1007/s12402-016-0212-7. Epub 2017 Jan 6.
- Derived from this study: PubMed 26329980Upadhyaya H, Tanaka Y, Lipsius S, Kryzhanovskaya LA, Lane JR, Escobar R, Trzepacz PT, Allen AJ. Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD. Postgrad Med. 2015;127(7):677-85. doi: 10.1080/00325481.2015.1083394. Epub 2015 Sep 2.
- Derived from this study: PubMed 23648011Upadhyaya H, Adler LA, Casas M, Kutzelnigg A, Williams D, Tanaka Y, Arsenault J, Escobar R, Allen AJ. Baseline characteristics of European and non-European adult patients with attention deficit hyperactivity disorder participating in a placebo-controlled, randomized treatment study with atomoxetine. Child Adolesc Psychiatry Ment Health. 2013 May 6;7(1):14. doi: 10.1186/1753-2000-7-14.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5hours, EST) study director
Eli Lilly and Company
56 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atomoxetine hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 56 sites in 12 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 3 inclusion and 5 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 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Germany, France, Belgium, Netherlands, Spain and 7 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. Some participants in this study may receive a placebo. 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 29 May 2013). 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?
Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period (time frame: Baseline (Week 24) up to Week 49). 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 NCT00700427, which also lists 3 linked publications.
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 26 Jun 2014.