HypercholesteremiaNCT00347217

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

An observational study of Hypercholesteremia, run by AstraZeneca at 215 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hypercholesteremia
How many people: 3,840 participants
Where: 215 sitesNetherlands
Study dates: Feb 2006to Jan 2009
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Clinic

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

215 sites in 1 country.

City, postcode or hospital

215 sites in 1 country

Netherlands215 sites

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

Other trials in Netherlands

About this study

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.

Conditions: Hypercholesteremia
Keywords: Cholesterol, rosuvastatin, LDL-C goal, observational study, primary prevention, secondary prevention
Medical subject headings: Hypercholesterolemia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Jan 2009

First posted4 Jul 2006 (estimated)
Study startFeb 2006
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypercholesteremiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 3,840 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00347217
Sponsor's protocol ID: NL401345
Other IDs: OPTIMAL
Status last verified: Aug 2011
First submitted: 30 Jun 2006
Last updated: 30 Aug 2011
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesteremia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00347217
Acronym / sponsor ID: NL401345
Conditions: Hypercholesteremia
Keywords: Cholesterol, rosuvastatin, LDL-C goal, observational study, primary prevention, secondary prevention
Study type: Observational
Recruitment status: Completed
Enrolment: 3,840 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2006
Study completion: Jan 2009 (actual)
First posted: 4 Jul 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Clinic

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.

Related trials for Hypercholesteremia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Netherlands Medical Director, MD study director

AstraZeneca

215 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercholesteremia, run by AstraZeneca at 215 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00347217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.