Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women

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NCT00163163

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Study Location
Pfizer Investigational Site
Afsnee Gent, , 9051, Belgium
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolaemia
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Postmenopausal women defined as having Age =< 70 years with documented menopause

- Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet

- Triglycerides =< 4 g/l(4.52 mmol/l)

- Informed, written consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Age > 70 years


- Unconfirmed menopause


- Overall duration of treatment with any HMG-CoA Reductase inhibitor > 3 months within
the last year


- Patient treated with any lipid-lowering drugs within the last 6 weeks preceding the
randomization


- History of myocardial infarction, coronary bypass surgery, angioplasty, stroke or TIA


- CPK levels > 3 times upper limit of normal


- Body Mass Index >= 30

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HypercholesterolaemiaCarotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women NCT00163163
  1. Afsnee Gent,
  2. Assenede,
  3. Brussels,
  4. Bruxelles,
  5. Bruxelles,
  6. Bruxelles,
  7. Bruxelles,
  8. Bruxelles,
  9. Ertvelde,
  10. Gent,
  11. Linkebeek,
  12. Sint-niklaas,
  13. Tielt,
  14. Wetteren,
  15. Wondelgem,
  16. Achenheim,
  17. Ancerville,
  18. Augny,
  19. Bar Le Duc,
  20. Boersch,
  21. Bois-Colombes,
  22. Boissy Saint Leger,
  23. Bouzonville,
  24. Colombey-Les-Belles,
  25. Dammarie Les Lys,
  26. Docelles,
  27. Dourdan,
  28. Eckbolsheim,
  29. Epinay S/orge,
  30. Etampes,
  31. Frouard,
  32. Gambsheim,
  33. Haguenau,
  34. Kilstett,
  35. Laxou,
  36. le Grand Quevilly,
  37. Le Mesnil Esnard,
  38. Leuville Sur Orge,
  39. Lingolsheim,
  40. Longpont Sur Orge,
  41. Mars LA Tour,
  42. Metz,
  43. Moutiers,
  44. Nancy,
  45. Nancy,
  46. Nancy,
  47. Paris,
  48. Paris,
  49. Paris,
  50. Paris,
  51. Paris,
  52. Pont a Mousson,
  53. Pont-a-mousson,
  54. Pulnoy,
  55. Rouen,
  56. Sainte Genevieve Des Bois,
  57. Sauvigny,
  58. Savigny Sur Orge,
  59. Sotteville Les Rouen Cedex,
  60. Souffelweyersheim,
  61. St Max,
  62. Strasbourg,
  63. Strasbourg,
  64. Terville,
  65. Toul,
  66. Vandoeuvre Les Nancy,
  67. Vandoeuvre,
  68. Verdun,
  69. Vincennes,
  70. Ed Voerendaal,
  71. En Vaals,
  72. Ve Maastricht,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
Official Title  ICMJE Carotid Atorvastatin Study In Hyperlipidemic Post-Menopausal Women: A Randomized Evaluation of Atorvastatin, Versus Placebo (CASHMERE)
Brief Summary To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolaemia
Intervention  ICMJE
  • Procedure: Echographic measurements
  • Procedure: Blood samples
Study Arms  ICMJE Not Provided
Publications * Gompel A, Boutouyrie P, Joannides R, Christin-Maitre S, Kearny-Schwartz A, Kunz K, Laurent S, Boivin JM, Pannier B, Pornel B, Struijker-Boudier HA, Thuillez C, Van Bortel L, Zannad F, Pithois-Merli I, Jaillon P, Simon T. Association of menopause and hormone replacement therapy with large artery remodeling. Fertil Steril. 2011 Dec;96(6):1445-50. doi: 10.1016/j.fertnstert.2011.09.010. Epub 2011 Oct 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)		400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal women defined as having Age =< 70 years with documented menopause
  • Fasting LDL cholesterol 130 mg/ dl (3.37 mmol/l)and =< 190 mg/ dl (4.92 mmol/l) after 6 weeks of diet
  • Triglycerides =< 4 g/l(4.52 mmol/l)
  • Informed, written consent

Exclusion Criteria:

  • Age > 70 years
  • Unconfirmed menopause
  • Overall duration of treatment with any HMG-CoA Reductase inhibitor > 3 months within the last year
  • Patient treated with any lipid-lowering drugs within the last 6 weeks preceding the randomization
  • History of myocardial infarction, coronary bypass surgery, angioplasty, stroke or TIA
  • CPK levels > 3 times upper limit of normal
  • Body Mass Index >= 30
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163163
Other Study ID Numbers  ICMJE A2581051
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP