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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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00347217
Collaborator
(none)
3,840
Enrollment
215
Locations
35
Duration (Months)
17.9
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3840 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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 Start Date :
    Feb 1, 2006
    Actual Study Completion Date :
    Jan 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Research Site 's-gravenhage Netherlands
      2 Research Site 's-hertogenbosch Netherlands
      3 Research Site 't Zand Nh Netherlands
      4 Research Site Alblasserdam Netherlands
      5 Research Site Alkmaar Netherlands
      6 Research Site Almelo Netherlands
      7 Research Site Almere Netherlands
      8 Research Site Alphen Aan Den Rijn Netherlands
      9 Research Site Amersfoort Netherlands
      10 Research Site Amstelveen Netherlands
      11 Research Site Amsterdam Zuidoost Netherlands
      12 Research Site Amsterdam Netherlands
      13 Research Site Andijk Netherlands
      14 Research Site Apeldoorn Netherlands
      15 Research Site Appingedam Netherlands
      16 Research Site Arkel Netherlands
      17 Research Site Arnemuiden Netherlands
      18 Research Site Arnhem Netherlands
      19 Research Site Assen Netherlands
      20 Research Site Axel Netherlands
      21 Research Site Baarlo Lb Netherlands
      22 Research Site Baarn Netherlands
      23 Research Site Barendrecht Netherlands
      24 Research Site Bavel Netherlands
      25 Research Site Beek En Donk Netherlands
      26 Research Site Bennekom Netherlands
      27 Research Site Benningbroek Netherlands
      28 Research Site Bergen Op Zoom Netherlands
      29 Research Site Best Netherlands
      30 Research Site Beverwijk Netherlands
      31 Research Site Bladel Netherlands
      32 Research Site Blaricum Netherlands
      33 Research Site Boskoop Netherlands
      34 Research Site Breda Netherlands
      35 Research Site Brunssum Netherlands
      36 Research Site Budel Dorplein Netherlands
      37 Research Site Budel Netherlands
      38 Research Site Bunde Netherlands
      39 Research Site Castricum Netherlands
      40 Research Site Coevorden Netherlands
      41 Research Site Cuijk Netherlands
      42 Research Site Darp Netherlands
      43 Research Site Delft Netherlands
      44 Research Site Delfzijl Netherlands
      45 Research Site Den Helder Netherlands
      46 Research Site Deurne Netherlands
      47 Research Site Didam Netherlands
      48 Research Site Doesburg Netherlands
      49 Research Site Doetinchem Netherlands
      50 Research Site Dokkum Netherlands
      51 Research Site Dordrecht Netherlands
      52 Research Site Dorst Netherlands
      53 Research Site Drachten Netherlands
      54 Research Site Drunen Netherlands
      55 Research Site Easterein Netherlands
      56 Research Site Echt Netherlands
      57 Research Site Edam Netherlands
      58 Research Site EDE Netherlands
      59 Research Site Eersel Netherlands
      60 Research Site Egmond Aan Den Hoef Netherlands
      61 Research Site Eindhoven Netherlands
      62 Research Site Elim Netherlands
      63 Research Site Elspeet Netherlands
      64 Research Site Emmeloord Netherlands
      65 Research Site Emmen Netherlands
      66 Research Site Enkhuizen Netherlands
      67 Research Site Enschede Netherlands
      68 Research Site Ermelo Netherlands
      69 Research Site Etten-leur Netherlands
      70 Research Site Franeker Netherlands
      71 Research Site Geldrop Netherlands
      72 Research Site Geleen Netherlands
      73 Research Site Gemert Netherlands
      74 Research Site Gouda Netherlands
      75 Research Site Groet Netherlands
      76 Research Site Groningen Netherlands
      77 Research Site Haarlem Netherlands
      78 Research Site Hardenberg Netherlands
      79 Research Site Harderwijk Netherlands
      80 Research Site Harlingen Netherlands
      81 Research Site Harskamp Netherlands
      82 Research Site Heel Netherlands
      83 Research Site Heemskerk Netherlands
      84 Research Site Heerenveen Netherlands
      85 Research Site Heerlen Netherlands
      86 Research Site Heiloo Netherlands
      87 Research Site Hellevoetsluis Netherlands
      88 Research Site Helmond Netherlands
      89 Research Site Hendrik Ido Ambacht Netherlands
      90 Research Site Hengelo Ov Netherlands
      91 Research Site Herten Netherlands
      92 Research Site Heythuysen Netherlands
      93 Research Site Hilversum Netherlands
      94 Research Site Hoenderloo Netherlands
      95 Research Site Hoofddorp Netherlands
      96 Research Site Hoogeveen Netherlands
      97 Research Site Huizen Netherlands
      98 Research Site Ijmuiden Netherlands
      99 Research Site Ijsselstein Ut Netherlands
      100 Research Site Joure Netherlands
      101 Research Site Kerkrade Netherlands
      102 Research Site Klazienaveen Netherlands
      103 Research Site Krimpen Aan Den Ijssel Netherlands
      104 Research Site Landgraaf Netherlands
      105 Research Site Landsmeer Netherlands
      106 Research Site Laren Nh Netherlands
      107 Research Site Leeuwarden Netherlands
      108 Research Site Leiden Netherlands
      109 Research Site Leidschendam Netherlands
      110 Research Site Lemmer Netherlands
      111 Research Site Lichtenvoorde Netherlands
      112 Research Site Limmen Netherlands
      113 Research Site Losser Netherlands
      114 Research Site Lunteren Netherlands
      115 Research Site Maasbracht Netherlands
      116 Research Site Maassluis Netherlands
      117 Research Site Maastricht Netherlands
      118 Research Site Malden Netherlands
      119 Research Site Marssum Netherlands
      120 Research Site Meijel Netherlands
      121 Research Site Melick Netherlands
      122 Research Site Monster Netherlands
      123 Research Site Musselkanaal Netherlands
      124 Research Site Naarden Netherlands
      125 Research Site Nieuwegein Netherlands
      126 Research Site Nijmegen Netherlands
      127 Research Site Nunspeet Netherlands
      128 Research Site Oegstgeest Netherlands
      129 Research Site Oirschot Netherlands
      130 Research Site Oldebroek Netherlands
      131 Research Site Oldenzaal Netherlands
      132 Research Site Onstwedde Netherlands
      133 Research Site OSS Netherlands
      134 Research Site Ottersum Netherlands
      135 Research Site Oude Pekela Netherlands
      136 Research Site Oudega Gem Smallingerlnd Netherlands
      137 Research Site Papendrecht Netherlands
      138 Research Site Pernis Rotterdam Netherlands
      139 Research Site Poeldijk Netherlands
      140 Research Site Prinsenbeek Netherlands
      141 Research Site Purmerend Netherlands
      142 Research Site Putten Netherlands
      143 Research Site Ridderkerk Netherlands
      144 Research Site Rijsbergen Netherlands
      145 Research Site Rijssen Netherlands
      146 Research Site Rijswijk Zh Netherlands
      147 Research Site Rockanje Netherlands
      148 Research Site Roden Netherlands
      149 Research Site Rosmalen Netherlands
      150 Research Site Rotterdam Netherlands
      151 Research Site Rottevalle Netherlands
      152 Research Site Ruinen Netherlands
      153 Research Site Schijndel Netherlands
      154 Research Site Schoonhoven Netherlands
      155 Research Site Sint Annaparochie Netherlands
      156 Research Site Sint Geertruid Netherlands
      157 Research Site Sint Michielsgestel Netherlands
      158 Research Site Sint Odilienberg Netherlands
      159 Research Site Sint Philipsland Netherlands
      160 Research Site Sint Willebrord Netherlands
      161 Research Site Sittard Netherlands
      162 Research Site Sliedrecht Netherlands
      163 Research Site Sneek Netherlands
      164 Research Site Soest Netherlands
      165 Research Site Spijkenisse Netherlands
      166 Research Site Steenwijk Netherlands
      167 Research Site Stiens Netherlands
      168 Research Site Swifterbant Netherlands
      169 Research Site Ten Boer Netherlands
      170 Research Site Ter Aar Netherlands
      171 Research Site Ter Apel Netherlands
      172 Research Site Terborg Netherlands
      173 Research Site Terneuzen Netherlands
      174 Research Site Tiel Netherlands
      175 Research Site Tienhoven Ut Netherlands
      176 Research Site Tilburg Netherlands
      177 Research Site Tubbergen Netherlands
      178 Research Site Uden Netherlands
      179 Research Site Utrecht Netherlands
      180 Research Site Vaassen Netherlands
      181 Research Site Valkenswaard Netherlands
      182 Research Site Veenendaal Netherlands
      183 Research Site Veghel Netherlands
      184 Research Site Velden Netherlands
      185 Research Site Veldhoven Netherlands
      186 Research Site Venlo Netherlands
      187 Research Site Venray Netherlands
      188 Research Site Vinkeveen Netherlands
      189 Research Site Vlaardingen Netherlands
      190 Research Site Vleuten Netherlands
      191 Research Site Vlissingen Netherlands
      192 Research Site Volendam Netherlands
      193 Research Site Volkel Netherlands
      194 Research Site Voorburg Netherlands
      195 Research Site Waalre Netherlands
      196 Research Site Waddinxveen Netherlands
      197 Research Site Weert Netherlands
      198 Research Site Westerhaar-vriezenv Wijk Netherlands
      199 Research Site Westervoort Netherlands
      200 Research Site Wezep Netherlands
      201 Research Site Wijnjewoude Netherlands
      202 Research Site Wildervank Netherlands
      203 Research Site Woerden Netherlands
      204 Research Site Wolvega Netherlands
      205 Research Site Wouterswoude Netherlands
      206 Research Site Zaandam Netherlands
      207 Research Site Zeist Netherlands
      208 Research Site Zevenaar Netherlands
      209 Research Site Zevenhuizen Gn Netherlands
      210 Research Site Zoetermeer Netherlands
      211 Research Site Zuidland Netherlands
      212 Research Site Zuidlaren Netherlands
      213 Research Site Zundert Netherlands
      214 Research Site Zwaagwesteinde Netherlands
      215 Research Site Zwolle Netherlands

      Sponsors and Collaborators

      • AstraZeneca

      Investigators

      • Study Director: AstraZeneca Netherlands Medical Director, MD, AstraZeneca

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      AstraZeneca
      ClinicalTrials.gov Identifier:
      NCT00347217
      Other Study ID Numbers:
      • NL401345
      • OPTIMAL
      First Posted:
      Jul 4, 2006
      Last Update Posted:
      Aug 30, 2011
      Last Verified:
      Aug 1, 2011
      Keywords provided by AstraZeneca
      Cholesterol
      rosuvastatin
      LDL-C goal
      observational study
      primary prevention
      secondary prevention
      Additional relevant MeSH terms:
      Hypercholesterolemia

      Study Results

      No Results Posted as of Aug 30, 2011