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PF-00217830

Phase 2

Schizophrenia | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Apr 18, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment164

FDA Designations

No designations recorded

Clinical trial landscape

PF-00217830 · 1 trial · 1 indication

Phase 2 1
NCT00580125Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of SchizophreniaSchizophrenia
COMPLETED164 Analytics
PHASE2COMPLETED
Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
5 weeks
Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
5 weeks
Positive and Negative Symptom Scale (PANSS) total score.
Screening, Day 1, 3, 7, 14 and 21
Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup),
5 weeks
Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).
4 weeks

Secondary Endpoints

PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
Screening, Day 1, 3, 7, 14 and 21
PANSS positive, negative, and general psychopathology subscales
Screening, Day 1, 3, 7, 14 and 21
Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
Screening and Days 1, 3, 7, 14 and 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A2EXPERIMENTAL -
A5PLACEBO_COMPARATOR -
A4ACTIVE_COMPARATOR -
A3EXPERIMENTAL -
A1EXPERIMENTAL -

Interventions

NameTypeDescription
PF-00217830DRUGPF-00217830 5 mg, oral capsule, once daily for 21 days
PlaceboOTHERPlacebo, oral capsule, once daily for 21 days
AripiprazoleDRUGAripiprazole 15 mg, oral capsule, once daily for 21 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: Key inclusion criteria include: * Have a current diagnosis of schizophrenia. * Increase in symptoms over the past 2-4 weeks. * Willing to remain inpatients for the duration of the trial. Exclusion Criteria: * Subjects with a current DSM-IV axis I diagnosis other than schizoph...

Countries:United StatesIndiaRussiaUkraine
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Frequently asked questions about PF-00217830

What is PF-00217830 used for in schizophrenia?

PF-00217830 is an investigational small molecule being studied for the treatment of schizophrenia. It was evaluated in a Phase 2 clinical trial for acute exacerbation of schizophrenia. The drug is not approved and remains in clinical development.

Who makes PF-00217830?

PF-00217830 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company sponsored the clinical trial of this investigational drug for schizophrenia.

What phase is PF-00217830 in?

PF-00217830 is in Phase 2 clinical development. It has completed one Phase 2 trial for schizophrenia, but it is not approved by regulatory authorities and remains investigational.

What clinical trials is PF-00217830 in?

PF-00217830 has one completed Phase 2 clinical trial, identified as NCT00580125. This was a dose-response study evaluating the safety, efficacy, and pharmacokinetics of PF-00217830 compared with placebo in patients with acute exacerbation of schizophrenia.

Was PF-00217830 tested in a randomized controlled trial?

Yes, PF-00217830 was tested in a randomized, double-blind, placebo-controlled Phase 2 trial. The study enrolled 164 participants with schizophrenia across the United States, India, Russia, and Ukraine, and it has been completed.