CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)
CARIATIDE
An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman
1 other identifier
observational
2,600
17 countries
158
Brief Summary
This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Typical duration for all trials
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 20, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJanuary 18, 2016
October 1, 2011
3 years
May 20, 2008
January 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.
once after one year
Secondary Outcomes (3)
Persistence rate will be evaluated for the first time after one year and a second time after two years. The Investigator will ask the subject about her persistence as follows:
After one and two years.
Time to treatment discontinuation is defined as number of days between the date of first and last intake of AI medication. Dates for AI treatment start and discontinuation will be documented in the CRF.
After one and two years
Reasons for discontinuation of AI: recurrence, death, physician's recommendation, interactions with other medication, side effects, treatment with other hormone medication than anastrozole or letrozole, unfilled AI prescription, subject's wish, other.
After one and two years
Study Arms (2)
1
Standard therapy
2
Standard therapy + educational material
Eligibility Criteria
Postmenopausal women with hormone sensitive early breast cancer that have been prescribed adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The adjuvant AI medication must not have exceeded thirteen weeks of treatment duration.
You may qualify if:
- Postmenopausal woman with hormone sensitive early breast cancer
- Documented decision of treatment with upfront adjuvant AI (either anastrozole or letrozole) according to current SmPC OR current treatment with AI (either anastrozole or letrozole) according to current SmPC, that has not exceeded thirteen weeks
You may not qualify if:
- Upfront adjuvant AI medication which has exceeded thirteen weeks at randomisation
- Concomitant adjuvant treatment with tamoxifen or exemestane
- Previous use of adjuvant tamoxifen or exemestane exceeding thirteen weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (164)
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Canberra, Australian Capital Territory, Australia
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Coffs Harbour, New South Wales, Australia
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Newcastle, New South Wales, Australia
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Port Macquarie, New South Wales, Australia
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Tweed Heads, New South Wales, Australia
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Brisbane, Queensland, Australia
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Nambour, Queensland, Australia
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Toowoomba, Queensland, Australia
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Hobart, Tasmania, Australia
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Sankt Veit im Jauntal, Carinthia, Austria
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Wolfsberg, Carinthia, Austria
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Salzburg, Salzburg, Austria
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Weiz, Styria, Austria
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Linz, Upper Austria, Austria
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Vienna, Vienna, Austria
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Aalst, Belgium
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Antwerp, Belgium
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Arlon, Belgium
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Bonheiden, Belgium
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Bornem, Belgium
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Boussu, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Dendermonde, Belgium
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Edegem, Belgium
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Eupen, Belgium
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Geel, Belgium
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Geraardsbergen, Belgium
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Ghent, Belgium
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Gilly, Belgium
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Haine-Saint-Paul, Belgium
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Leuven, Belgium
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Libramont, Belgium
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Liège, Belgium
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Namur, Belgium
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Ostend, Belgium
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Ottignies, Belgium
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Overpelt, Belgium
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Rocourt, Belgium
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Seraing, Belgium
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Tournai, Belgium
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Turnhout, Belgium
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Temuco, Región de la Araucanía, Chile
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Santiago, Santiago Metropolitan, Chile
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, Colombia
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Neiva, Huila Department, Colombia
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Pasto, Nari?o, Colombia
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Cali, Valle del Cauca Department, Colombia
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Osijek, Croatia
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Rijeka, Croatia
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Zagreb, Croatia
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Hradec Králové, Czechia
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Opava, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Helsinki, Finland
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Tampere, Finland
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Alès, Ales, France
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Annecy, Annecy, France
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Arpajon, Arpajon, France
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Beauvais, Beauvais, France
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Bordeaux, Bordeaux, France
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Brest, Brest, France
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Brive-la-Gaillarde, Brive La Gaillarde, France
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Dechy, Dechy, France
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Évreux, Evreux, France
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Grenoble, Grenoble, France
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Hyères, Hyeres, France
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Limoges, Limoges, France
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Lyon, Lyon, France
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Marseille, Marseille, France
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Mont-de-Marsan, Mont de Marsan, France
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Mougins, Mougins, France
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Nantes, Nantes, France
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Nice, Nice, France
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Nîmes, Nimes, France
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Périgueux, Perigueux, France
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Perpignan, Perpignan, France
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Reims, Reims, France
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Rennes, Rennes, France
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Rouen, Rouen, France
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Saint Brieux, Saint Brieux, France
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Saint-Cyr-sur-Loire, Saint Cyr Sur Loire, France
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Saint-Grégoire, Saint Gregoire, France
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Saint-Nazaire, Saint Nazaire, France
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Toulon, Toulon, France
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Toulouse, Toulouse, France
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Valence, Valence, France
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Villeneuve-sur-Lot, Villeneuve Sur Lot, France
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Aix-en-Provence, France
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Avignon, France
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Colmar, France
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Créteil, France
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Cucq, France
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Gap, France
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La Seyne-sur-Mer, France
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Mareuil-lès-Meaux, France
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Nancy, France
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Narbonne, France
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Quimper, France
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Saint-Jean, France
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Saint-Mandé, France
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Strasbourg, France
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Thonon-les-Bains, France
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Vannes, France
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Pátrai, Achaia, Greece
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Athens, Athens, Greece
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Piraeous, Piraeous, Greece
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Thessaloniki, Thessaloniki, Greece
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Trikala, Trikala, Greece
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Bologna, Bologna, Italy
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Cosenza, Cosenza, Italy
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Lido di Camaiore, Lucca, Italy
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Pavia, Pavia, Italy
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Roma, Roma, Italy
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Treviso, Treviso, Italy
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Lima, Lima Province, Peru
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Piura, Piura, Peru
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Alba Iulia, Romania
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Baia Mare, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Oradea, Romania
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Suceava, Romania
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Karlskrona, Karlskrona, Sweden
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Skellefte?, Skellefte?, Sweden
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Stockholm, Stockholm County, Sweden
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Baden, Switzerland
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Bern, Switzerland
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Lugano, Switzerland
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Sankt Gallen, Switzerland
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Zurich, Switzerland
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Ankara, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Eskişehir, Turkey (Türkiye)
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Gaziantep, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kayseri, Turkey (Türkiye)
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Konya, Turkey (Türkiye)
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Malatya, Turkey (Türkiye)
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Mersin, Turkey (Türkiye)
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St Albans, Hertfordshire, United Kingdom
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Brighton, United Kingdom
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Bristol, United Kingdom
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Cardiff, United Kingdom
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Cheltenham, United Kingdom
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Coventry, United Kingdom
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Dundee, United Kingdom
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Edinburgh, United Kingdom
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Glasgow, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Macclesfield, United Kingdom
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Manchester, United Kingdom
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Northwood, United Kingdom
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Nottingham, United Kingdom
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Scarborough, United Kingdom
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Shrewsbury, United Kingdom
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York, United Kingdom
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Valencia, Carabobo, Venezuela
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Caracas, Distrito Federal, Venezuela
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neven, P. Prof.
KUL
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2008
First Posted
May 21, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
January 18, 2016
Record last verified: 2011-10