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NCT00601523 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
NCT00601523: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00601523 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 511 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00601523, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
Study Summary
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).
Primary Outcome
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation
Interventions
- DRUG Placebo
- DRUG Pramipexole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00601523 record still lists
NCT00601523 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00601523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00601523 about?
NCT00601523 is a clinical study titled "Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).". The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).
What is the current status of trial NCT00601523?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2008-01.
What interventions are being tested in trial NCT00601523?
The interventions under investigation include: Placebo (DRUG), Pramipexole (DRUG).
Who is sponsoring clinical trial NCT00601523?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00601523's enrollment target sits among peer trials
511 728th of 2000 higher than 1,272 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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