Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00479401 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 539
- Enrollment target
NCT00479401 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 539 participants.
The verdict
NCT00479401, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 539 participants
- Enrollment target
Study Summary
The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole. In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity
Interventions
- DRUG Placebo
- DRUG Pramipexol Extended Release
- DRUG Pramipexol Immediate Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 539 participants |
| Start Date | 2007-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00479401
The ClinicalTrials.gov registry entry for NCT00479401 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 539 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 3 interventions - of which Placebo is the first listed.
NCT00479401 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00479401 about?
NCT00479401 is a clinical study titled "Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients". The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety,...
What is the current status of trial NCT00479401?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 539 participants. The study started on 2007-05.
What interventions are being tested in trial NCT00479401?
The interventions under investigation include: Placebo (DRUG), Pramipexol Extended Release (DRUG), Pramipexol Immediate Release (DRUG).
Who is sponsoring clinical trial NCT00479401?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.