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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 511 participants.

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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).

Interventions

  • DRUG Placebo
  • DRUG Pramipexole

Trial Details

FieldValue
Enrollment Target 511 participants
Start Date 2008-01
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT00601523

The ClinicalTrials.gov registry entry for NCT00601523 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 511 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.

NCT00601523 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.