Clinical trial NCT00347217: Observational to Investigate the Efficacy of CRESTOR 5mg in Reaching LDL-C Target Goals in Patients Who Are at High Risk for a Cardiovascular Event
Official title: An Observational Study Into the Usage and Efficacy of Crestor 5mg as a Start Dosage in Achieving the LDL-C Target Level in Both Statin-naive and Treated Primary and Secondary Prevention Patients With a High Risk of a Cardiovascular Event.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesteremia
Keywords: Cholesterol
rosuvastatin
LDL-C goal
observational study
primary prevention
secondary prevention
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 3840
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: 's-gravenhage
country: Netherlands
facility: Research Site
city: 's-hertogenbosch
country: Netherlands
facility: Research Site
city: 't Zand Nh
country: Netherlands
facility: Research Site
city: Alblasserdam
country: Netherlands
facility: Research Site
city: Alkmaar
country: Netherlands
facility: Research Site
city: Almelo
country: Netherlands
facility: Research Site
city: Almere
country: Netherlands
facility: Research Site
city: Alphen Aan Den Rijn
country: Netherlands
facility: Research Site
city: Amersfoort
country: Netherlands
facility: Research Site
city: Amstelveen
country: Netherlands
facility: Research Site
city: Amsterdam Zuidoost
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Andijk
country: Netherlands
facility: Research Site
city: Apeldoorn
country: Netherlands
facility: Research Site
city: Appingedam
country: Netherlands
facility: Research Site
city: Arkel
country: Netherlands
facility: Research Site
city: Arnemuiden
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Assen
country: Netherlands
facility: Research Site
city: Axel
country: Netherlands
facility: Research Site
city: Baarlo Lb
country: Netherlands
facility: Research Site
city: Baarn
country: Netherlands
facility: Research Site
city: Barendrecht
country: Netherlands
facility: Research Site
city: Bavel
country: Netherlands
facility: Research Site
city: Beek En Donk
country: Netherlands
facility: Research Site
city: Bennekom
country: Netherlands
facility: Research Site
city: Benningbroek
country: Netherlands
facility: Research Site
city: Bergen Op Zoom
country: Netherlands
facility: Research Site
city: Best
country: Netherlands
facility: Research Site
city: Beverwijk
country: Netherlands
facility: Research Site
city: Bladel
country: Netherlands
facility: Research Site
city: Blaricum
country: Netherlands
facility: Research Site
city: Boskoop
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Brunssum
country: Netherlands
facility: Research Site
city: Budel Dorplein
country: Netherlands
facility: Research Site
city: Budel
country: Netherlands
facility: Research Site
city: Bunde
country: Netherlands
facility: Research Site
city: Castricum
country: Netherlands
facility: Research Site
city: Coevorden
country: Netherlands
facility: Research Site
city: Cuijk
country: Netherlands
facility: Research Site
city: Darp
country: Netherlands
facility: Research Site
city: Delft
country: Netherlands
facility: Research Site
city: Delfzijl
country: Netherlands
facility: Research Site
city: Den Helder
country: Netherlands
facility: Research Site
city: Deurne
country: Netherlands
facility: Research Site
city: Didam
country: Netherlands
facility: Research Site
city: Doesburg
country: Netherlands
facility: Research Site
city: Doetinchem
country: Netherlands
facility: Research Site
city: Dokkum
country: Netherlands
facility: Research Site
city: Dordrecht
country: Netherlands
facility: Research Site
city: Dorst
country: Netherlands
facility: Research Site
city: Drachten
country: Netherlands
facility: Research Site
city: Drunen
country: Netherlands
facility: Research Site
city: Easterein
country: Netherlands
facility: Research Site
city: Echt
country: Netherlands
facility: Research Site
city: Edam
country: Netherlands
facility: Research Site
city: EDE
country: Netherlands
facility: Research Site
city: Eersel
country: Netherlands
facility: Research Site
city: Egmond Aan Den Hoef
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Elim
country: Netherlands
facility: Research Site
city: Elspeet
country: Netherlands
facility: Research Site
city: Emmeloord
country: Netherlands
facility: Research Site
city: Emmen
country: Netherlands
facility: Research Site
city: Enkhuizen
country: Netherlands
facility: Research Site
city: Enschede
country: Netherlands
facility: Research Site
city: Ermelo
country: Netherlands
facility: Research Site
city: Etten-leur
country: Netherlands
facility: Research Site
city: Franeker
country: Netherlands
facility: Research Site
city: Geldrop
country: Netherlands
facility: Research Site
city: Geleen
country: Netherlands
facility: Research Site
city: Gemert
country: Netherlands
facility: Research Site
city: Gouda
country: Netherlands
facility: Research Site
city: Groet
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Haarlem
country: Netherlands
facility: Research Site
city: Hardenberg
country: Netherlands
facility: Research Site
city: Harderwijk
country: Netherlands
facility: Research Site
city: Harlingen
country: Netherlands
facility: Research Site
city: Harskamp
country: Netherlands
facility: Research Site
city: Heel
country: Netherlands
facility: Research Site
city: Heemskerk
country: Netherlands
facility: Research Site
city: Heerenveen
country: Netherlands
facility: Research Site
city: Heerlen
country: Netherlands
facility: Research Site
city: Heiloo
country: Netherlands
facility: Research Site
city: Hellevoetsluis
country: Netherlands
facility: Research Site
city: Helmond
country: Netherlands
facility: Research Site
city: Hendrik Ido Ambacht
country: Netherlands
facility: Research Site
city: Hengelo Ov
country: Netherlands
facility: Research Site
city: Herten
country: Netherlands
facility: Research Site
city: Heythuysen
country: Netherlands
facility: Research Site
city: Hilversum
country: Netherlands
facility: Research Site
city: Hoenderloo
country: Netherlands
facility: Research Site
city: Hoofddorp
country: Netherlands
facility: Research Site
city: Hoogeveen
country: Netherlands
facility: Research Site
city: Huizen
country: Netherlands
facility: Research Site
city: Ijmuiden
country: Netherlands
facility: Research Site
city: Ijsselstein Ut
country: Netherlands
facility: Research Site
city: Joure
country: Netherlands
facility: Research Site
city: Kerkrade
country: Netherlands
facility: Research Site
city: Klazienaveen
country: Netherlands
facility: Research Site
city: Krimpen Aan Den Ijssel
country: Netherlands
facility: Research Site
city: Landgraaf
country: Netherlands
facility: Research Site
city: Landsmeer
country: Netherlands
facility: Research Site
city: Laren Nh
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Leidschendam
country: Netherlands
facility: Research Site
city: Lemmer
country: Netherlands
facility: Research Site
city: Lichtenvoorde
country: Netherlands
facility: Research Site
city: Limmen
country: Netherlands
facility: Research Site
city: Losser
country: Netherlands
facility: Research Site
city: Lunteren
country: Netherlands
facility: Research Site
city: Maasbracht
country: Netherlands
facility: Research Site
city: Maassluis
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Malden
country: Netherlands
facility: Research Site
city: Marssum
country: Netherlands
facility: Research Site
city: Meijel
country: Netherlands
facility: Research Site
city: Melick
country: Netherlands
facility: Research Site
city: Monster
country: Netherlands
facility: Research Site
city: Musselkanaal
country: Netherlands
facility: Research Site
city: Naarden
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Nunspeet
country: Netherlands
facility: Research Site
city: Oegstgeest
country: Netherlands
facility: Research Site
city: Oirschot
country: Netherlands
facility: Research Site
city: Oldebroek
country: Netherlands
facility: Research Site
city: Oldenzaal
country: Netherlands
facility: Research Site
city: Onstwedde
country: Netherlands
facility: Research Site
city: OSS
country: Netherlands
facility: Research Site
city: Ottersum
country: Netherlands
facility: Research Site
city: Oude Pekela
country: Netherlands
facility: Research Site
city: Oudega Gem Smallingerlnd
country: Netherlands
facility: Research Site
city: Papendrecht
country: Netherlands
facility: Research Site
city: Pernis Rotterdam
country: Netherlands
facility: Research Site
city: Poeldijk
country: Netherlands
facility: Research Site
city: Prinsenbeek
country: Netherlands
facility: Research Site
city: Purmerend
country: Netherlands
facility: Research Site
city: Putten
country: Netherlands
facility: Research Site
city: Ridderkerk
country: Netherlands
facility: Research Site
city: Rijsbergen
country: Netherlands
facility: Research Site
city: Rijssen
country: Netherlands
facility: Research Site
city: Rijswijk Zh
country: Netherlands
facility: Research Site
city: Rockanje
country: Netherlands
facility: Research Site
city: Roden
country: Netherlands
facility: Research Site
city: Rosmalen
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Rottevalle
country: Netherlands
facility: Research Site
city: Ruinen
country: Netherlands
facility: Research Site
city: Schijndel
country: Netherlands
facility: Research Site
city: Schoonhoven
country: Netherlands
facility: Research Site
city: Sint Annaparochie
country: Netherlands
facility: Research Site
city: Sint Geertruid
country: Netherlands
facility: Research Site
city: Sint Michielsgestel
country: Netherlands
facility: Research Site
city: Sint Odilienberg
country: Netherlands
facility: Research Site
city: Sint Philipsland
country: Netherlands
facility: Research Site
city: Sint Willebrord
country: Netherlands
facility: Research Site
city: Sittard
country: Netherlands
facility: Research Site
city: Sliedrecht
country: Netherlands
facility: Research Site
city: Sneek
country: Netherlands
facility: Research Site
city: Soest
country: Netherlands
facility: Research Site
city: Spijkenisse
country: Netherlands
facility: Research Site
city: Steenwijk
country: Netherlands
facility: Research Site
city: Stiens
country: Netherlands
facility: Research Site
city: Swifterbant
country: Netherlands
facility: Research Site
city: Ten Boer
country: Netherlands
facility: Research Site
city: Ter Aar
country: Netherlands
facility: Research Site
city: Ter Apel
country: Netherlands
facility: Research Site
city: Terborg
country: Netherlands
facility: Research Site
city: Terneuzen
country: Netherlands
facility: Research Site
city: Tiel
country: Netherlands
facility: Research Site
city: Tienhoven Ut
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Tubbergen
country: Netherlands
facility: Research Site
city: Uden
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Vaassen
country: Netherlands
facility: Research Site
city: Valkenswaard
country: Netherlands
facility: Research Site
city: Veenendaal
country: Netherlands
facility: Research Site
city: Veghel
country: Netherlands
facility: Research Site
city: Velden
country: Netherlands
facility: Research Site
city: Veldhoven
country: Netherlands
facility: Research Site
city: Venlo
country: Netherlands
facility: Research Site
city: Venray
country: Netherlands
facility: Research Site
city: Vinkeveen
country: Netherlands
facility: Research Site
city: Vlaardingen
country: Netherlands
facility: Research Site
city: Vleuten
country: Netherlands
facility: Research Site
city: Vlissingen
country: Netherlands
facility: Research Site
city: Volendam
country: Netherlands
facility: Research Site
city: Volkel
country: Netherlands
facility: Research Site
city: Voorburg
country: Netherlands
facility: Research Site
city: Waalre
country: Netherlands
facility: Research Site
city: Waddinxveen
country: Netherlands
facility: Research Site
city: Weert
country: Netherlands
facility: Research Site
city: Westerhaar-vriezenv Wijk
country: Netherlands
facility: Research Site
city: Westervoort
country: Netherlands
facility: Research Site
city: Wezep
country: Netherlands
facility: Research Site
city: Wijnjewoude
country: Netherlands
facility: Research Site
city: Wildervank
country: Netherlands
facility: Research Site
city: Woerden
country: Netherlands
facility: Research Site
city: Wolvega
country: Netherlands
facility: Research Site
city: Wouterswoude
country: Netherlands
facility: Research Site
city: Zaandam
country: Netherlands
facility: Research Site
city: Zeist
country: Netherlands
facility: Research Site
city: Zevenaar
country: Netherlands
facility: Research Site
city: Zevenhuizen Gn
country: Netherlands
facility: Research Site
city: Zoetermeer
country: Netherlands
facility: Research Site
city: Zuidland
country: Netherlands
facility: Research Site
city: Zuidlaren
country: Netherlands
facility: Research Site
city: Zundert
country: Netherlands
facility: Research Site
city: Zwaagwesteinde
country: Netherlands
facility: Research Site
city: Zwolle
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Netherlands Medical Director, MD
role: STUDY_DIRECTOR
References: