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Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

NCT ID: NCT01170091

Last Updated: 2014-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

651 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Brief Summary

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Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

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A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS

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Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)

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Detailed Description

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Study Design:

Conditions

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Restless Legs Syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Pramipexole

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Moderate to severe Primary Restless Legs Syndrome
2. Male or female patients aged at least 18 years

Exclusion Criteria

1. Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with Mirapex
3. Pregnant and breastfeeding women
4. Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa)
5. Secondary RLS
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site 1

Busan, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 2

Busan, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 3

Busan, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 32

Daegu, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 33

Daegu, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 34

Daejeon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 35

Daejeon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 36

Deajeon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 25

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 26

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 27

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 28

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 29

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 30

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 31

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 10

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 11

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 12

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 13

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 14

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 15

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 16

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 17

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 18

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 19

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 20

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 21

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 22

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 23

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 24

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 4

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 5

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 6

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 7

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 8

Seoul, , South Korea

Site Status

Boehringer Ingelheim Investigational Site 9

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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248.653

Identifier Type: -

Identifier Source: org_study_id

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