Trials / Completed
CompletedNCT00134966
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 493 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
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.).
Detailed description
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 100 mg t.i.d.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) |
Timeline
- Start date
- 2005-08-01
- Primary completion
- 2007-09-01
- Completion
- 2007-09-01
- First posted
- 2005-08-25
- Last updated
- 2017-05-17
Locations
60 sites across 8 countries: United States, Canada, Czechia, Israel, Italy, Poland, Portugal, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT00134966. Inclusion in this directory is not an endorsement.