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Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients

NCT01191944 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 475

Last updated 2014-10-31

Study results available
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Summary

The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .

Conditions

  • Parkinson Disease

Interventions

DRUG

pramipexole immediate release tablet

0.375mg-4.5mg(daily dose), three times a day

DRUG

pramipexole extended release tablet

0.375mg-4.5mg, once a day

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01191944 on ClinicalTrials.gov