Caduet in an Untreated Subject Population

NCT00332761

Last updated date
Study Location
Pfizer Investigational Site
Jonesboro, Arkansas, 72401, United States
Contact
1-800-718-1021

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

By email

Contact

[email protected]

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

- Subjects who were recently diagnosed with both hypertension and dyslipidemia and who are not yet taking any medications for these conditions OR subjects with both hypertension and dyslipidemia who were previously treated with antihypertensive and/or lipid lowering medications but discontinued these medications for at least 3 months prior to the Screening visit.

- SBP 140-169 mmHg and/or DBP 90-105 mmHg, LDL-C 110-160 mg/dL

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


- Subjects with a history of MI, angina, coronary artery bypass or intra-coronary
interventions, stroke, TIA, CHF or cardiomyopathy requiring treatment.


- Subjects with a known history of Type I or Type 2 Diabetes Mellitus or a fasting blood
glucose > 126 mg/dL at the Screening visit.

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Pfizer Clinical Trials Contact Center

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  2. Little Rock, Arkansas
  3. Garden Grove, California
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  5. Tustin, California
  6. Aventura, Florida
  7. Ft. Lauderdale, Florida
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  10. Atlanta, Georgia
  11. Decatur, Georgia
  12. Bossier City, Louisiana
  13. Fair Haven, Michigan
  14. Livonia, Michigan
  15. Jackson, Mississippi
  16. Jackson, Mississippi
  17. Excelsior Springs, Missouri
  18. Berlin, New Jersey
  19. Elizabeth, New Jersey
  20. Princeton, New Jersey
  21. South Bound Brook, New Jersey
  22. Binghamton, New York
  23. Monroe, North Carolina
  24. Winston-Salem, North Carolina
  25. Cincinnati, Ohio
  26. Dayton, Ohio
  27. Eugene, Oregon
  28. Bensalem, Pennsylvania
  29. Kingsport, Tennessee
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  5. Calgary, Alberta
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  8. Chilliwack, British Columbia
  9. New Westminster, British Columbia
  10. North Vancouver, British Columbia
  11. Quesnel, British Columbia
  12. Vancouver, British Columbia
  13. Vancouver, British Columbia
  14. Vancouver, British Columbia
  15. Vancouver, British Columbia
  16. Vancouver, British Columbia
  17. Winnipeg, Manitoba
  18. Winnipeg, Manitoba
  19. Antigonish, Nova Scotia
  20. Digby, Nova Scotia
  21. Halifax, Nova Scotia
  22. Halifax, Nova Scotia
  23. Truro, Nova Scotia
  24. Wolfville, Nova Scotia
  25. Alymer, Ontario
  26. Corunna, Ontario
  27. Exeter, Ontario
  28. Hamilton, Ontario
  29. Kingston, Ontario
  30. London, Ontario
  31. London, Ontario
  32. London, Ontario
  33. London, Ontario
  34. London, Ontario
  35. London, Ontario
  36. London, Ontario
  37. North York, Ontario
  38. North York, Ontario
  39. Oshawa, Ontario
  40. Oshawa, Ontario
  41. Peterborough, Ontario
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  43. Toronto, Ontario
  44. Toronto, Ontario
  45. Toronto, Ontario
  46. Toronto, Ontario
  47. Waterloo, Ontario
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  49. Whitby, Ontario
  50. Charlottetown, Prince Edward Island
  51. Bonaventure, Quebec
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  53. Gatineau, Quebec
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  55. Longueuil, Quebec
  56. Montreal, Quebec
  57. Montreal, Quebec
  58. Pointe-Claire, Quebec
  59. Sherbrooke, Quebec
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  61. St-Georges Ouest, Quebec
  62. St-Marc Des Carrieres, Quebec
  63. St. Lambert, Quebec
  64. Ste-foy, Quebec
  65. Regina, Saskatchewan
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  69. Rimouski,
  70. St-Gedeon Beauce,
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  78. Fowey, Cornwall
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  13. Jacksonville, Florida
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  20. Atlanta, Georgia
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  22. Augusta, Georgia
  23. Columbus, Georgia
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  25. Decatur, Georgia
  26. Lincolnton, Georgia
  27. Savannah, Georgia
  28. Chicago, Illinois
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  31. Merrillville, Indiana
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  33. Bossier City, Louisiana
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  35. New Orleans, Louisiana
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  37. Shreveport, Louisiana
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  39. Baltimore, Maryland
  40. Columbia, Maryland
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  44. Brockton, Massachusetts
  45. Wellesley Hills, Massachusetts
  46. Detroit, Michigan
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  48. Lansing, Michigan
  49. Livonia, Michigan
  50. Jackson, Mississippi
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  53. Kansas City, Missouri
  54. St. Louis, Missouri
  55. St. Louis, Missouri
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  67. Mineola, New York
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  70. Monroe, North Carolina
  71. Monroe, North Carolina
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  74. Cincinnati, Ohio
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  78. Dayton, Ohio
  79. Dayton, Ohio
  80. Maumee, Ohio
  81. Perrysburg, Ohio
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Advanced Information
Descriptive Information
Brief Title  ICMJE Caduet in an Untreated Subject Population
Official Title  ICMJE An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial Examining The Efficacy And Safety Of Caduet® In Simultaneously Achieving Blood Pressure And Lipid Goals In An Untreated Hypertensive And Dyslipidemic Subject Population. (CUSP - Caduet in Untreated Subject Population)
Brief Summary The purpose of this study is to determine if Caduet will lower blood pressure to <140/90 mmHg and lower LDL Cholesterol to <100 mg/dL in subjects with hypertension and dyslipidemia who are not currently being treated for these medical conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Dyslipidemia
Intervention  ICMJE Drug: Caduet
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: June 1, 2006)
220
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who were recently diagnosed with both hypertension and dyslipidemia and who are not yet taking any medications for these conditions OR subjects with both hypertension and dyslipidemia who were previously treated with antihypertensive and/or lipid lowering medications but discontinued these medications for at least 3 months prior to the Screening visit.
  • SBP 140-169 mmHg and/or DBP 90-105 mmHg, LDL-C 110-160 mg/dL

Exclusion Criteria:

  • Subjects with a history of MI, angina, coronary artery bypass or intra-coronary interventions, stroke, TIA, CHF or cardiomyopathy requiring treatment.
  • Subjects with a known history of Type I or Type 2 Diabetes Mellitus or a fasting blood glucose > 126 mg/dL at the Screening visit.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00332761
Other Study ID Numbers  ICMJE A3841046
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2008

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