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NCT00134966 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 493
- Enrollment target
NCT00134966 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 493 participants.
The verdict
NCT00134966, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 493 participants
- Enrollment target
Study Summary
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
Interventions
- DRUG capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 493 participants |
| Start Date | 2005-08 |
| Est. Completion | 2007-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00134966
The ClinicalTrials.gov registry entry for NCT00134966 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 493 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) is the first listed.
NCT00134966 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00134966 about?
NCT00134966 is a clinical study titled "A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa". The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate rel...
What is the current status of trial NCT00134966?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 493 participants. The study started on 2005-08. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00134966?
The interventions under investigation include: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) (DRUG).
Who is sponsoring clinical trial NCT00134966?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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