Non-interventional Observational Study of Pramipexole in Restless Legs Syndrome: Impact on Quality of Life

NCT ID: NCT00539461

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2023 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Brief Summary

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In this German non-interventional observational study 1980 patients diagnosed with Restless Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal states in Germany. Both moderate to severe RLS patients, with or without previous RLS treatment, suffering from RLS symptoms like a desire to move the extremities usually associated with some discomfort, motor restlessness and worsening of symptoms at rest with at least temporary relief by activity, worsening of symptoms later in the day or at night, are eligible for this study, if it is planned to initiate therapy with pramipexole or to add pramipexole to a previously given, insufficient therapy. Three visits are planned to be documented in this PMS study, one baseline visit, visit two after the end of pramipexole titration and visit three after 12 weeks of treatment. Evaluations and visits are to be carried out and documented only if part of routine medical practice. The main goal of observational studies is to determine how pramipexole treatment works when applied in actual practice and thus maximise external validity. In actual practice patients who have been excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will be treated with PPX. Thus in addition during this observational study information on the efficacy and safety of PPX in those patients will be obtained. The objectives of this PMS study are:

* To evaluate the treatment effect of pramipexole on RLS severity and general improvement as measured by IRLS and CGI-I.
* To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome Quality of Life questionnaire (RLS-QoL).
* To evaluate the safety profile of PPX in a natural study population.

Detailed Description

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Conditions

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Restless Legs Syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of primary RLS
2. Indication for RLS treatment with Sifrol® (pramipexole)
3. Male or female patients aged at least 18 years.

Exclusion Criteria

1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with Sifrol® (pramipexole).
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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Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Aalen, , Germany

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Aarbergen, , Germany

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Adendorf, , Germany

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Aham, , Germany

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Ahaus, , Germany

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Ahlen, , Germany

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Ahorntal, , Germany

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Aichach, , Germany

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Aislingen, , Germany

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Albstadt, , Germany

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Aldenhoven, , Germany

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Aldingen, , Germany

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Alfeld, , Germany

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Alpirsbach, , Germany

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Alsdorf, , Germany

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Altena, , Germany

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Altenstadt, , Germany

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Altomünster, , Germany

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Alveslohe, , Germany

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Amberg, , Germany

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Ammerbuch, , Germany

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Andernach, , Germany

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Anklam, , Germany

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Apolda, , Germany

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Armsheim, , Germany

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Arzberg, , Germany

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Aschaffenburg, , Germany

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Aschersleben, , Germany

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Aschheim, , Germany

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Attendorn, , Germany

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Auerbach, , Germany

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Augsburg, , Germany

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Aurich, , Germany

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Babensham, , Germany

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Backnang, , Germany

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Bad Arolsen, , Germany

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Bad Berleburg, , Germany

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Bad Bevensen, , Germany

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Bad Düben, , Germany

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Bad Dürrenberg, , Germany

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Bad Dürrheim, , Germany

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Bad Ems, , Germany

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Bad Essen, , Germany

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Bad Kreuznach, , Germany

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Bad Laasphe, , Germany

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Bad Langensalza, , Germany

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Bad Lausick, , Germany

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Bad Münstereifel, , Germany

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Bad Oeynhausen, , Germany

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Bad Salzungen, , Germany

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Bad Schwalbach, , Germany

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Bad Schwartau, , Germany

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Bad Segeberg, , Germany

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Bad Tennstedt, , Germany

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Bad Waldsee, , Germany

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Baden-Baden, , Germany

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Bahrdorf, , Germany

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Baltmannsweiler, , Germany

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Bamberg, , Germany

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Barleben, , Germany

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Baunatal, , Germany

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Bautzen, , Germany

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Bayreuth, , Germany

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Bärnau, , Germany

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Beckum, , Germany

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Beeskow, , Germany

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Bellheim, , Germany

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Belm, , Germany

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Bensheim, , Germany

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Berching, , Germany

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Bergfelde, , Germany

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Bergheim, , Germany

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Bergisch Gladbach, , Germany

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Berkheim, , Germany

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Berlin, , Germany

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Berne, , Germany

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Bernsdorf, , Germany

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Betzdorf, , Germany

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Biebertal, , Germany

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Bielefeld, , Germany

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Bienenbüttel, , Germany

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Bippen, , Germany

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Birkenfeld, , Germany

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Birkenwerder, , Germany

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Blankenhain, , Germany

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Blaustein, , Germany

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Blieskastel, , Germany

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Bobritzsch, , Germany

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Bocholt, , Germany

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Bochum, , Germany

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Bockenem, , Germany

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Bodelshausen, , Germany

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Bodenfelde, , Germany

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Bodenkirchen, , Germany

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Bodenwöhr, , Germany

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Bodman-Ludwigshafen, , Germany

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Bollendorf, , Germany

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Bonn, , Germany

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Bopfingen, , Germany

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Borgholzhausen, , Germany

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Borken, , Germany

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Borna, , Germany

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Bornheim, , Germany

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Bottendorf, , Germany

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Bottmersdorf, , Germany

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Bottrop, , Germany

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Bovenden, , Germany

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Böhlen, , Germany

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Bösel, , Germany

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Brake, , Germany

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Brandenburg, , Germany

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Brannenburg, , Germany

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Braunschweig, , Germany

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Brechen, , Germany

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Breitenbrunn, , Germany

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Bremen, , Germany

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Bremerhaven, , Germany

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Brensbach, , Germany

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Breuberg, , Germany

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Bruchköbel, , Germany

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Brunsbüttel, , Germany

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Buchbach, , Germany

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Buckow, , Germany

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Buedelsdorf, , Germany

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Burg, , Germany

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Burgau, , Germany

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Burgdorf, Hanover, , Germany

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Burgpreppach, , Germany

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Burtenbach, , Germany

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Buttstädt, , Germany

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Butzbach, , Germany

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Bückeburg, , Germany

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Bünde, , Germany

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Büttelborn, , Germany

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Cadolzburg, , Germany

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Calbe, , Germany

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Calberlah, , Germany

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Castrop-Rauxel, , Germany

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Celle, , Germany

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Chemnitz, , Germany

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Cochem, , Germany

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Coppenbrügge, , Germany

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Crimmitschau, , Germany

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Crivitz, , Germany

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Cuxhaven, , Germany

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Dabel, , Germany

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Darmstadt, , Germany

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Dassow, , Germany

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Datteln, , Germany

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Daun, , Germany

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Deggendorf, , Germany

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Deidesheim, , Germany

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Deining, , Germany

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Delitzsch, , Germany

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Demen, , Germany

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Denkendorf, , Germany

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Dessau, , Germany

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Detmold, , Germany

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Dettenheim, , Germany

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Deuben, , Germany

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Deutzen, , Germany

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Diepholz, , Germany

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Dillingen, , Germany

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Dingolfing, , Germany

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Dinkelsbühl, , Germany

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Dinslaken, , Germany

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Dissen, , Germany

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Dogern, , Germany

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Dollern, , Germany

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Donaueschingen, , Germany

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Dormagen, , Germany

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Dornstetten, , Germany

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Dorsten, , Germany

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Dortmund, , Germany

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Dörentrup, , Germany

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Dörpen, , Germany

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Dreieich, , Germany

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Drensteinfurt, , Germany

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Dresden, , Germany

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Driedorf, , Germany

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Duderstadt, , Germany

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Duisburg, , Germany

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Dummerstorf, , Germany

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Düren, , Germany

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Düsseldorf, , Germany

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Ebergötzen, , Germany

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Ebermannstadt, , Germany

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Eberstadt, , Germany

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Ebhausen, , Germany

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Edewecht, , Germany

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Edling, , Germany

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Egelsbach, , Germany

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Ehingen, , Germany

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Eilenburg, , Germany

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Eisenhüttenstadt, , Germany

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Eiterfeld, , Germany

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Eitorf, , Germany

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Ellwangen, , Germany

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Elmshorn, , Germany

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Emersacker, , Germany

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Emmendingen, , Germany

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Emsdetten, , Germany

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Enger, , Germany

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Enkenbach-Alsenborn, , Germany

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Ennepetal, , Germany

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Ennigerloh, , Germany

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Eppstein, , Germany

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Erding, , Germany

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Erftstadt, , Germany

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Erkrath, , Germany

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Erligheim, , Germany

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Erndtebrück, , Germany

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Erolzheim, , Germany

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Eschborn, , Germany

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Eschelbronn, , Germany

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Eschweiler, , Germany

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Eslohe, , Germany

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Espenhain, , Germany

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Essen, , Germany

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Esslingen am Neckar, , Germany

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Euskirchen, , Germany

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Filderstadt, , Germany

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Floh-Seligenthal, , Germany

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Flöha, , Germany

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Forbach, , Germany

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Forchheim, , Germany

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Frankenberg, , Germany

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Frankenthal, , Germany

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Frankfurt, , Germany

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Freiberg, , Germany

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Freiburg im Breisgau, , Germany

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Freigericht, , Germany

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Freudenstadt, , Germany

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Freyung, , Germany

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Friedland, , Germany

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Friedrichshafen, , Germany

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Friedrichsthal, , Germany

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Frohburg, , Germany

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Fulda, , Germany

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Furtwangen im Schwarzwald, , Germany

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Fürstenwalde, , Germany

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Füssen, , Germany

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Gangelt, , Germany

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Gardelegen, , Germany

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Garmisch-Partenkirchen, , Germany

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Gars, , Germany

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Gebesee, , Germany

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Geesthacht, , Germany

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Gelbensande, , Germany

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Gelsenkirchen, , Germany

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Gensingen, , Germany

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Georgsmarienhütte, , Germany

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Gera, , Germany

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Gerbstedt, , Germany

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Germering, , Germany

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Germersheim, , Germany

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Gevelsberg, , Germany

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Giessen, , Germany

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Gifhorn, , Germany

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Gilserberg, , Germany

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Gladbeck, , Germany

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Gleichen, , Germany

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Goch, , Germany

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Gochsheim, , Germany

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Gomaringen, , Germany

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Göllheim, , Germany

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Göllingen, , Germany

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Göttingen, , Germany

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Grafenau, , Germany

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Gransee, , Germany

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Grassau, , Germany

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Greiz, , Germany

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Greven, , Germany

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Grevesmühlen, , Germany

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Griesheim, , Germany

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Gronau, , Germany

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Groß Grönau, , Germany

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Groß Quenstedt, , Germany

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Groß-Zimmern, , Germany

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Großalmerode, , Germany

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Großbottwar, , Germany

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Großefehn, , Germany

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Großhabersdorf, , Germany

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Großkorbetha, , Germany

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Großlangheim, , Germany

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Grömitz, , Germany

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Grünbach, , Germany

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Gummersbach, , Germany

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Güstrow, , Germany

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Haag, , Germany

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Hagen, , Germany

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Haigerloch, , Germany

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Haldensleben I, , Germany

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Halle, , Germany

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Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hamm, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hamminkeln, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hanau, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hanerau-Hademarschen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Harpstedt, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Harsefeld, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Harsewinkel, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Haselünne, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hattersheim, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hattingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Havixbeck, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hedersleben, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Heek, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Heide, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Heidelberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Heilbronn, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Heimsheim, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Heinsberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hellenthal, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hermaringen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Huska, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

248.638

Identifier Type: -

Identifier Source: org_study_id