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NCT00402233 · ClinicalTrials.gov registry record · Phase 4
A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 312
- Enrollment target
NCT00402233 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 312 participants.
The verdict
NCT00402233, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 312 participants
- Enrollment target
Study Summary
Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks
Interventions
- DRUG Placebo
- DRUG Pramipexole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2006-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00402233
The ClinicalTrials.gov registry entry for NCT00402233 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00402233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00402233 about?
NCT00402233 is a clinical study titled "A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients". Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among ...
What is the current status of trial NCT00402233?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 312 participants. The study started on 2006-11.
What interventions are being tested in trial NCT00402233?
The interventions under investigation include: Placebo (DRUG), Pramipexole (DRUG).
Who is sponsoring clinical trial NCT00402233?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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