SchizophreniaPhase 2NCT00686998
Phase IIA Study in Patients With Schizophrenia
A Phase 2 study testing AZD2624 and Olanzapine in people with Schizophrenia, run by AstraZeneca at 1 site in United States.
Trial summary
This study is designed to assess the effects of AZD 2624 in patients with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- AZD2624 and Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2009
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females of non-childbearing potential
- Diagnosis of Schizophrenia
Who cannot join
- Clinically relevant disease and /or abnormalities.
- Alcohol or substance abuse not in remission
- Enrollment in another investigational study within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD2624 in Adult Schizophrenia Patients
This study is designed to assess the effects of AZD 2624 in patients with schizophrenia
- Conditions
- Schizophrenia
- Being tested
- AZD2624, Olanzapine, Placebo
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2624Drug
Oral Suspension
OlanzapineDrug
Also called Zyprexa
PO BID
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AZD2624 | Experimental | AZD2624 40 mg Receives: Drug: AZD2624 |
| Olanzapine | Other | Olanzapine 15 mg Receives: Drug: Olanzapine |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.
Measured: Baseline, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
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.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dhaval Desai, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686998
- Sponsor's protocol ID
- D0970C00004
- Status last verified
- Mar 2013
- First submitted
- 28 May 2008
- Last updated
- 29 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD2624 in Adult Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT00686998
- Acronym / sponsor ID
- D0970C00004
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 23 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the effects of AZD 2624 in patients with schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZD2624 | Experimental | Drug: AZD2624AZD2624 40 mg |
| Olanzapine | Other | Drug: OlanzapineOlanzapine 15 mg |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females of non-childbearing potential
- Diagnosis of Schizophrenia
Key exclusion criteria (3 listed)
- Clinically relevant disease and /or abnormalities.
- Alcohol or substance abuse not in remission
- Enrollment in another investigational study within 30 days
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 |
|---|---|---|
| AZD2624Oral Suspension | Drug | AZD2624 |
| OlanzapineAlso: ZyprexaPO BID | Drug | Olanzapine |
| Placebo | Drug | Placebo |
Primary outcome
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
Time frame: Baseline, Day 28
PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dhaval Desai, MD study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD2624 and Olanzapine in people with Schizophrenia, run by AstraZeneca at 1 site in United States.
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 2 inclusion and 3 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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?
Yes. Results are posted in the registry (first posted 23 Jun 2011). 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?
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline (time frame: Baseline, Day 28). 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 29 Mar 2013.