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

This study has been completed.

First Received on July 26, 2010.  
Last Updated on May 18, 2012  
History of Changes
This Clinical Trial Sponsored By: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01170091
 

Purpose for Clinical Trial

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

Condition
Restless Legs Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Resource links provided by NLM:

MedlinePlus related topics:
Restless Legs
Drug Information available for:
Pramipexole dihydrochloride
Pramipexole

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment: 656
Study Start Date: December 2007
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts

Pramipexole

Detailed Description:

Study Design:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

3000

Criteria

Inclusion criteria

  1. Moderate to severe Primary Restless Legs Syndrome
  2. Male or female patients aged at least 18 years
  3. Indication for RLS treatment with Mirapex

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170091

Locations
Korea, Republic of
Boehringer Ingelheim Investigational Site 1
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 2
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 3
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 32
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 33
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 34
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 35
Daejeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 36
Deajeon, Korea, Republic of
Boehringer Ingelheim Investigational Site 29
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 30
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 31
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 28
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 27
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 25
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 26
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 16
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 17
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 18
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 19
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 20
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 21
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 22
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 23
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 24
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 5
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 6
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 7
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 8
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 9
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 10
Seoul, Korea, Republic of

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