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

August 29, 2011 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

3840

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • 's-gravenhage, Netherlands
        • Research Site
      • 's-hertogenbosch, Netherlands
        • Research Site
      • 't Zand Nh, Netherlands
        • Research Site
      • Alblasserdam, Netherlands
        • Research Site
      • Alkmaar, Netherlands
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      • Almelo, Netherlands
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      • Almere, Netherlands
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      • Alphen Aan Den Rijn, Netherlands
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      • Amersfoort, Netherlands
        • Research Site
      • Amstelveen, Netherlands
        • Research Site
      • Amsterdam, Netherlands
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      • Amsterdam Zuidoost, Netherlands
        • Research Site
      • 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
        • Research Site
      • 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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      • EDE, Netherlands
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      • Easterein, Netherlands
        • Research Site
      • Echt, Netherlands
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      • Edam, 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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      • 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
        • Research Site
      • Leidschendam, Netherlands
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      • Lemmer, Netherlands
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      • 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
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      • Marssum, Netherlands
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      • 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
      • OSS, Netherlands
        • Research Site
      • Oegstgeest, Netherlands
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      • Oirschot, Netherlands
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      • Oldebroek, Netherlands
        • Research Site
      • Oldenzaal, Netherlands
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      • Onstwedde, 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 Rotterdam, 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 Michielsgestel, Netherlands
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      • Sint Odilienberg, Netherlands
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      • Sint Philipsland, Netherlands
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      • Sint Willebrord, Netherlands
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      • Sittard, Netherlands
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      • Sliedrecht, Netherlands
        • Research Site
      • Sneek, Netherlands
        • Research Site
      • Soest, Netherlands
        • Research Site
      • Spijkenisse, Netherlands
        • Research Site
      • 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
        • Research Site
      • Tiel, Netherlands
        • Research Site
      • Tienhoven Ut, Netherlands
        • Research Site
      • Tilburg, Netherlands
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      • 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
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      • Vleuten, Netherlands
        • Research Site
      • Vlissingen, Netherlands
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      • Volendam, Netherlands
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      • 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, Netherlands
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 29, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL401345
  • OPTIMAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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