Attention Deficit Hyperactivity DisorderPhase 2NCT00562055
Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
A Phase 2 study testing Atomoxetine and PNU-165442G; [S,S]-reboxetine in people with Attention Deficit Hyperactivity Disorder, run by Pfizer.
Trial summary
This study will compare the safety and efficacy of [S,S]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine and PNU-165442G; [S,S]-reboxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria.
- Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale
- Score of 4 or higher on the Clinician Global Impression - Severity scale
Who cannot join
- Significant comorbid psychiatric diagnoses
- Significant risk of suicidal or violent behavior
About this study
Official title: Phase 2, Randomized, Double-Blind, Parallel-Group, Four Week, Efficacy And Safety Trial Of [S,S]-Reboxetine (PNU-165442g) And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
This study will compare the safety and efficacy of [S,S]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity disorder.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Atomoxetine, PNU-165442G; [S,S]-reboxetine
- 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.
AtomoxetineDrug
PNU-165442G; [S,S]-reboxetineDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: PNU-165442G; [S,S]-reboxetine |
| Arm B | Active comparator | Not described Receives: Drug: Atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult ADHD Investigator Symptom Rating Scale - Total Score
Measured: 4 weeks
Secondary outcomes (2)
Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score
Measured: 4 weeks
Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startNov 2007
Why it stopped: This study was withdrawn due to business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562055
- Sponsor's protocol ID
- A6061060
- Other IDs
- A6061060
- Status last verified
- Apr 2019
- First submitted
- 19 Nov 2007
- Last updated
- 16 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double-Blind, Parallel-Group, Four Week, Efficacy And Safety Trial Of [S,S]-Reboxetine (PNU-165442g) And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.
- ClinicalTrials.gov ID
- NCT00562055
- Acronym / sponsor ID
- A6061060
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn due to business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- First posted
- 21 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the safety and efficacy of [S,S]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: PNU-165442G; [S,S]-reboxetine |
| Arm B | Active comparator | Drug: Atomoxetine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria.
- Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale
- Score of 4 or higher on the Clinician Global Impression - Severity scale
Key exclusion criteria (2 listed)
- Significant comorbid psychiatric diagnoses
- Significant risk of suicidal or violent behavior
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 | Drug | Arm B |
| PNU-165442G; [S,S]-reboxetine | Drug | Arm A |
Primary outcome
Adult ADHD Investigator Symptom Rating Scale - Total Score
Time frame: 4 weeks
2 secondary outcomes
Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score
Time frame: 4 weeks
Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atomoxetine and PNU-165442G; [S,S]-reboxetine in people with Attention Deficit Hyperactivity Disorder, run by Pfizer.
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 2 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: withdrawn, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Adult ADHD Investigator Symptom Rating Scale - Total Score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2019.