PsychosisNCT00780585
A Follow up Safety Study of Patients Who Participated in Previous Studies of the Drug Org 24448 (Study P05719)(COMPLETED)
An observational study of Psychosis, run by Merck Sharp & Dohme LLC.
Trial summary
This is a safety study evaluating the subjects who participated in previous Organon trials of the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a possible Follow-Up period. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychosis
- What is being tested?
- SCH 900460
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Jan 2009
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects will be selected from subjects who participated in previous Org 24448 trials
Who may be able to join
- Subjects must:
- be verified by the investigator to have participated in a previous Organon sponsored Org 24448 trial.
- sign an affirmative informed consent before evaluations are conducted;
Who cannot join
- Subjects must not have:
- a concurrent acute condition that could interfere with the conduct or interpretation of the evaluations (e.g. acute psychosis; respiratory illness; current experimental medications). If possible, evaluation of such subjects is deferred until resolution of such conditions.
About this study
Official title: A Multi-center Cardiac Safety Study of Subjects Who Participated in Organon Sponsored Phase 1 and Phase 2 Completed and Discontinued Trials With Org 24448
This is a safety study evaluating the subjects who participated in previous Organon trials of the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a possible Follow-Up period. During the visits, study tests, including echocardiograms, will be performed to summarize cardiac functioning.
Read the detailed description
All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.
- Conditions
- Psychosis
- Being tested
- SCH 900460
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 900460Drug
Also called Org 24448
Subjects who participated in previous trials of Org 24448 (SCH 900460)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects who participated in previous Org 24448 trials Receives: Drug: SCH 900460 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cardiac function by cardiologist evaluation including echocardiogram.
Measured: During the Evaluation Period (Visit 1 or 2 and 3 if applicable).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780585
- Sponsor's protocol ID
- P05719
- Other IDs
- 2007-001611-32;, 153006
- Status last verified
- Dec 2014
- First submitted
- 23 Oct 2008
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Cardiac Safety Study of Subjects Who Participated in Organon Sponsored Phase 1 and Phase 2 Completed and Discontinued Trials With Org 24448
- ClinicalTrials.gov ID
- NCT00780585
- Acronym / sponsor ID
- P05719
- Conditions
- Psychosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Oct 2008 (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 is a safety study evaluating the subjects who participated in previous Organon trials of the drug Org 24448. Patients will undergo a Screening visit, 1 or 2 Evaluation visits, and a possible Follow-Up period. During the visits, study tests, including echocardiograms, will be performed to summarize cardiac functioning.
Detailed description
All subjects who participated in previous Org 24448 trials and who do not meet any of the exclusion criteria are eligible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: SCH 900460Subjects who participated in previous Org 24448 trials |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be selected from subjects who participated in previous Org 24448 trials
Key inclusion criteria (3 listed)
- be verified by the investigator to have participated in a previous Organon sponsored Org 24448 trial.
- sign an affirmative informed consent before evaluations are conducted;
Key exclusion criteria (2 listed)
- a concurrent acute condition that could interfere with the conduct or interpretation of the evaluations (e.g. acute psychosis; respiratory illness; current experimental medications). If possible, evaluation of such subjects is deferred until resolution of such conditions.
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 |
|---|---|---|
| SCH 900460Also: Org 24448Subjects who participated in previous trials of Org 24448 (SCH 900460) | Drug | 1 |
Primary outcome
Overall cardiac function by cardiologist evaluation including echocardiogram.
Time frame: During the Evaluation Period (Visit 1 or 2 and 3 if applicable).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis, run by Merck Sharp & Dohme LLC.
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: finished, as of the sponsor's last update on 19 Dec 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall cardiac function by cardiologist evaluation including echocardiogram. (time frame: During the Evaluation Period (Visit 1 or 2 and 3 if applicable).). 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 19 Dec 2014.