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NCT00391261 · ClinicalTrials.gov registry record · Phase 4
An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications.
A Phase 4 study, sponsored by Cambridge Health Alliance.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT00391261 is a Phase 4 study that has completed, run by Cambridge Health Alliance. The registered enrollment target is 11 participants.
The verdict
NCT00391261, a Phase 4 study, has completed, sponsored by Cambridge Health Alliance.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin treatment in children and adolescents suffering from weight gain secondary to use of atypical antipsychotic medications. In this 12 week, open-label study we will investigate metformin's effects on weight control and/or weight loss. We hypothesize that metformin would prevent further weight gain or lead to weight loss, resulting in amelioration of one of the most significant side effects of atypical antipsychotic use.
Interventions
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-07 |
| Est. Completion | 2007-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00391261
The ClinicalTrials.gov registry entry for NCT00391261 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cambridge Health Alliance, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Metformin is the first listed.
NCT00391261 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00391261 about?
NCT00391261 is a clinical study titled "An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications.". The aim of this study is to evaluate the effectiveness, safety, and tolerability of metformin treatment in children and adolescents suffering from weight gain secondary to use of atypical antipsychotic medications. In this 12 week, open-label study we will investigate metformin's effects on weight c...
What is the current status of trial NCT00391261?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2006-07. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00391261?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT00391261?
This trial is sponsored by Cambridge Health Alliance, which has 45 total clinical trials registered on ClinicalTrials.gov.
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