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AZD3480

Phase 2

ADHD | Small molecule | Psychiatry |AstraZeneca PLC|Trials Updated: Jul 23, 2014

AZD3480 development status

Highest phase Phase 2
Registered trials 10 across 1 sponsor since Jul 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials6
Total Enrollment1,179

FDA Designations

No designations recorded

AZD3480 clinical trials

AZD3480 · 6 trials · 5 indications

Phase 2 3Phase 1 3
NCT00683462An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)ADHD
COMPLETED24 Analytics
NCT00528905Proof of Concept Study of Cognitive Improvement in Patients With SchizophreniaSchizophrenia
COMPLETED400 Analytics
NCT00501111Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's DiseaseAlzheimer Disease
COMPLETED659 Analytics
PHASE2COMPLETED
An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
ADHDUnlock trial analytics
PHASE2COMPLETED
Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).
Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15
Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function
Change from baseline to Week 12
Change in ADAS-Cog
assessed after 12 weeks treatment
PK variables
Frequent sampling occasions during

Secondary Endpoints

Clinical Global Impressions Scales (NIMH 1985)
Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
CDR computerized cognitive battery
2, 3, 5, 8, 10, 13, 15
CNRU computerized cognitive battery
2, 3, 5, 8, 10, 13, 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATOR -
2EXPERIMENTAL -
3EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUG -
AZD3480DRUGCapsules 5 mg/day (once a day) for 2 weeks
DonepezilDRUG -
AripiprazoleDRUGsingle dose on day 5
Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)DRUGCocktail mix which contains the following: CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin) single dose of mix
WarfarinDRUGWarfarin: single dose on day 6
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Confirmed diagnosis of DSM-IV ADHD * Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV) * Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions...

Countries:United StatesCanadaAustriaBelgiumBulgariaCzechiaGermanyRomaniaRussiaSpainUnited KingdomSweden
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Competitive Landscape -ADHD 10 trials

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Frequently asked questions about AZD3480

What is AZD3480?

AZD3480 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for psychiatric and neurological conditions. It has been studied in ADHD, Alzheimer's disease, schizophrenia, and metabolism-related research. It is a Phase 2 clinical candidate and has not been approved for any indication.

What is AZD3480 used for?

AZD3480 has been studied for adult attention-deficit/hyperactivity disorder (ADHD), Alzheimer's disease, schizophrenia, and metabolism-related conditions. It remains investigational and is not approved for any use. Clinical trials have explored its effects in these indications, but no regulatory approval has been granted.

Who makes AZD3480?

AZD3480 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating AZD3480 in psychiatric and neurological indications.

What phase is AZD3480 in?

AZD3480 is in Phase 2 of clinical development. It has completed three Phase 1 drug interaction studies and one Phase 2 exploratory trial in adult ADHD. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is AZD3480 in?

AZD3480 has been evaluated in completed trials including NCT00692510 (drug interaction with cytochrome P450), NCT00689637 (interaction with warfarin), NCT00689559 (interaction with aripiprazole), and NCT00683462 (Phase 2 trial in adult ADHD). All trials are completed; no active trials are ongoing.

Is AZD3480 the same as TC-1734?

Yes, AZD3480 is also known as TC-1734. The Phase 2 trial NCT00683462 refers to the drug as AZD3480 (TC-1734), confirming they are the same compound. Both names refer to the same investigational small molecule developed by AstraZeneca.