NCT00347217

Brief Summary

Observational study to investigate the use and efficacy of CRESTOR 5 mg in reaching LDL-C target goals in both statin naïve and statin treated primary and secondary prevention patients at high risk for a cardiovascular event.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Typical duration for all trials

Geographic Reach
1 country

215 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

First QC Date

June 30, 2006

Last Update Submit

August 29, 2011

Conditions

Keywords

CholesterolrosuvastatinLDL-C goalobservational studyprimary preventionsecondary prevention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinic

You may qualify if:

  • The patient has a high risk of a cardiovascular event as defined by the European guidelines.
  • The patient is statin-naive (i.e. has not used a statin \> 2 months), or is currently treated with atorvastatin, pravastatin or simvastatin.
  • An LDL-C level is known for the statin-naive patient or for the statin used during visit 1.
  • It has been decided to start the patient on CRESTOR 5 mg.
  • The patient is prepared to give permission to the coded data being made available to AstraZeneca

You may not qualify if:

  • The patient is known to have complaints of myalgia, myopathy or liver function impairment (including elevated levels of serum transaminases) where there is a causal relationship with the statin treatment.
  • Contraindications for treatment with CRESTOR (see 1 B1 text).
  • Patients with a family history of dyslipidemias, for instance familiar (combined) hypercholesterolemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (215)

Research Site

's-Hertogenbosch, Netherlands

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't Zand Nh, Netherlands

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Alblasserdam, Netherlands

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Alkmaar, Netherlands

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Almelo, Netherlands

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Almere Stad, Netherlands

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Alphen aan den Rijn, Netherlands

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Amersfoort, Netherlands

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Amstelveen, Netherlands

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Amsterdam, Netherlands

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Amsterdam-Zuidoost, Netherlands

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Andijk, Netherlands

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Apeldoorn, Netherlands

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Appingedam, Netherlands

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Arkel, Netherlands

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Arnemuiden, Netherlands

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Arnhem, Netherlands

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Assen, Netherlands

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Axel, Netherlands

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Baarlo Lb, Netherlands

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Baarn, Netherlands

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Barendrecht, Netherlands

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Bavel, Netherlands

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Beek en Donk, Netherlands

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Bennekom, Netherlands

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Benningbroek, Netherlands

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Bergen op Zoom, Netherlands

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Best, Netherlands

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Beverwijk, Netherlands

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Bladel, Netherlands

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Blaricum, Netherlands

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Boskoop, Netherlands

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Breda, Netherlands

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Brunssum, Netherlands

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Budel, Netherlands

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Budel-Dorplein, Netherlands

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Bunde, Netherlands

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Castricum, Netherlands

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Coevorden, Netherlands

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Cuijk, Netherlands

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Darp, Netherlands

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Delft, Netherlands

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Delfzijl, Netherlands

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Den Helder, Netherlands

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Deurne, Netherlands

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Didam, Netherlands

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Doesburg, Netherlands

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Doetinchem, Netherlands

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Dokkum, Netherlands

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Dordrecht, Netherlands

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Dorst, Netherlands

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Drachten, Netherlands

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Drunen, Netherlands

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Echt, Netherlands

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Edam, Netherlands

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Ede, Netherlands

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Eersel, Netherlands

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Egmond aan den Hoef, Netherlands

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Eindhoven, Netherlands

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Elim, Netherlands

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Elspeet, Netherlands

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Emmeloord, Netherlands

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Emmen, Netherlands

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Enkhuizen, Netherlands

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Enschede, Netherlands

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Ermelo, Netherlands

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Etten-Leur, Netherlands

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Flushing, Netherlands

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Franeker, Netherlands

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Geldrop, Netherlands

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Geleen, Netherlands

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Gemert, Netherlands

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Gouda, Netherlands

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Groet, Netherlands

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Groningen, Netherlands

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Haarlem, Netherlands

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Hardenberg, Netherlands

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Harderwijk, Netherlands

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Harlingen, Netherlands

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Harskamp, Netherlands

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Heel, Netherlands

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Heemskerk, Netherlands

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Heerenveen, Netherlands

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Heerlen, Netherlands

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Heiloo, Netherlands

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Hellevoetsluis, Netherlands

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Helmond, Netherlands

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Hendrik-Ido-Ambacht, Netherlands

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Hengelo Ov, Netherlands

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Herten, Netherlands

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Heythuysen, Netherlands

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Hilversum, Netherlands

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Hoenderloo, Netherlands

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Hoofddorp, Netherlands

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Hoogeveen, Netherlands

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Huizen, Netherlands

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IJmuiden, Netherlands

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Ijsselstein Ut, Netherlands

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Joure, Netherlands

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Kerkrade, Netherlands

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Klazienaveen, Netherlands

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Krimpen aan den IJssel, Netherlands

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Landgraaf, Netherlands

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Landsmeer, Netherlands

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Laren Nh, Netherlands

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Leeuwarden, Netherlands

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Leiden, Netherlands

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Leidschendam, Netherlands

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Lemmer, Netherlands

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Lichtenvoorde, Netherlands

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Limmen, Netherlands

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Losser, Netherlands

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Lunteren, Netherlands

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Maasbracht, Netherlands

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Maassluis, Netherlands

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Maastricht, Netherlands

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Malden, Netherlands

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Marsum, Netherlands

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Meijel, Netherlands

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Melick, Netherlands

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Monster, Netherlands

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Musselkanaal, Netherlands

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Naarden, Netherlands

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Nieuwegein, Netherlands

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Nijmegen, Netherlands

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Nunspeet, Netherlands

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Oegstgeest, Netherlands

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Oirschot, Netherlands

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Oldebroek, Netherlands

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Oldenzaal, Netherlands

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Onstwedde, Netherlands

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Oosterend, Netherlands

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Oss, Netherlands

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Ottersum, Netherlands

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Oude Pekela, Netherlands

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Oudega Gem Smallingerlnd, Netherlands

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Papendrecht, Netherlands

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Pernis, Netherlands

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Poeldijk, Netherlands

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Prinsenbeek, Netherlands

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Purmerend, Netherlands

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Putten, Netherlands

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Ridderkerk, Netherlands

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Rijsbergen, Netherlands

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Rijssen, Netherlands

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Rijswijk Zh, Netherlands

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Rockanje, Netherlands

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Roden, Netherlands

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Rosmalen, Netherlands

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Rotterdam, Netherlands

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Rottevalle, Netherlands

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Ruinen, Netherlands

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Schijndel, Netherlands

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Schoonhoven, Netherlands

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Sint Annaparochie, Netherlands

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Sint Geertruid, Netherlands

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Sint Odiliënberg, Netherlands

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Sint Philipsland, Netherlands

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Sint Willebrord, Netherlands

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Sint-Michielsgestel, Netherlands

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Sittard, Netherlands

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Sliedrecht, Netherlands

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Sneek, Netherlands

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Soest, Netherlands

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Spijkenisse, Netherlands

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Steenwijk, Netherlands

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Stiens, Netherlands

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Swifterbant, Netherlands

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Ten Boer, Netherlands

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Ter Aar, Netherlands

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Ter Apel, Netherlands

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Terborg, Netherlands

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Terneuzen, Netherlands

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The Hague, Netherlands

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Tiel, Netherlands

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Tienhoven Ut, Netherlands

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Tilburg, Netherlands

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Tubbergen, Netherlands

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Uden, Netherlands

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Utrecht, Netherlands

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Vaassen, Netherlands

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Valkenswaard, Netherlands

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Veenendaal, Netherlands

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Veghel, Netherlands

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Velden, Netherlands

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Veldhoven, Netherlands

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Venlo, Netherlands

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Venray, Netherlands

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Vinkeveen, Netherlands

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Vlaardingen, Netherlands

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Vleuten, Netherlands

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Volendam, Netherlands

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Volkel, Netherlands

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Voorburg, Netherlands

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Waalre, Netherlands

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Waddinxveen, Netherlands

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Wâlterswâld, Netherlands

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Weert, Netherlands

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Westerhaar-vriezenv Wijk, Netherlands

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Westervoort, Netherlands

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Wezep, Netherlands

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Wijnjewoude, Netherlands

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Wildervank, Netherlands

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Woerden, Netherlands

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Wolvega, Netherlands

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Zaandam, Netherlands

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Zeist, Netherlands

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Zevenaar, Netherlands

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Zevenhuizen Gn, Netherlands

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Zoetermeer, Netherlands

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Zuidland, Netherlands

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Zuidlaren, Netherlands

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Zundert, Netherlands

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Zwaagwesteinde, Netherlands

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Zwolle, Netherlands

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MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • AstraZeneca Netherlands Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

February 1, 2006

Study Completion

January 1, 2009

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations