Trials / Completed
CompletedNCT00623103
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 583 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivastigmine capsule | Rivastigmine capsules orally twice a day. Target dose 12 mg/day. |
| DRUG | Rivastigmine transdermal patch | Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period. |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2010-11-01
- First posted
- 2008-02-25
- Last updated
- 2011-11-28
- Results posted
- 2011-11-28
Locations
127 sites across 13 countries: United States, Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00623103. Inclusion in this directory is not an endorsement.