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

Hypercholesteremia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347217
• Other study ID #: NL401345
• Secondary ID: OPTIMAL
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2006
• Last updated: August 29, 2011
• Start date: February 2006
• Est. completion date: January 2009

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3840
• Est. completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypercholesteremia
• Hypercholesterolemia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands,