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NCT00139594 · ClinicalTrials.gov registry record · Phase 4
Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
A Phase 4 study of Bipolar Disorder, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 181
- Enrollment target
- 20
- Study locations
NCT00139594 is a Phase 4 study of Bipolar Disorder that has completed, run by Novartis. The registered enrollment target is 181 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT00139594, a Phase 4 study of Bipolar Disorder, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 181 participants
- Enrollment target
- 20
- Study locations
Study Summary
This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.
Conditions Studied
Interventions
- DRUG licarbazepine
Study Locations (20)
Other
- Novartis Investigational Site - Vienna
- Novartis Investigational Site - Greater Sudbury
- Novartis Investigational Site - Kelowna
- Novartis Investigational Site - London
- Novartis Investigational Site - Montreal
- Novartis Investigator Site - Vancouver
- Novartis Investigational Site - Bogotá
Texas
- Novartis Investigational Site - Bellaire
- Novartis Investigational Site - Dallas
- Novartis Investigational Site - Verdun
Washington
- Novartis Investigational Site - Bellevue
- Novartis Investigational Site - Kirkland
California
- Investigational site - La Palma
Kansas
- Novartis Investigational Site - Kansas City
Louisiana
- Novartis Investigational Site - Shreveport
Massachusetts
- Novartis Investigational Site - Somerville
Michigan
- Novartis Investigational Site - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2004-12 |
| Est. Completion | 2007-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00139594
The ClinicalTrials.gov registry entry for NCT00139594 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (45% lower). The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which licarbazepine is the first listed.
NCT00139594 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Texas, Washington.
Frequently Asked Questions
What is clinical trial NCT00139594 about?
NCT00139594 is a clinical study titled "Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder". This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.
What is the current status of trial NCT00139594?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 181 participants. The study started on 2004-12. Estimated completion is 2007-07.
What conditions does trial NCT00139594 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00139594?
The interventions under investigation include: licarbazepine (DRUG).
Who is sponsoring clinical trial NCT00139594?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00139594 being conducted?
This trial has 20 study locations across California, Kansas, Louisiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.