A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

NCT00412113

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dyslipidemia, Hypertension
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 with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

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


- Subjects who are taking the following prohibited medications within 14 days of
screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3
antihypertensive agents (including Norvasc)


- Subjects that have not been on a stable dose of Norvasc for at least 4 weeks


- Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular
Disease (PVD)

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Dyslipidemia, HypertensionA Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
NCT00412113
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Mesa, Arizona
  5. Garden Grove, California
  6. Mission Viejo, California
  7. Rancho Santa Margarita, California
  8. Torrance, California
  9. Gainesville, Florida
  10. Kissimmee, Florida
  11. Melbourne, Florida
  12. Miami, Florida
  13. Safety Harbor, Florida
  14. St. Petersburg, Florida
  15. Augusta, Georgia
  16. Tucker, Georgia
  17. South Bend, Indiana
  18. Erlanger, Kentucky
  19. Auburn, Maine
  20. Warren, Michigan
  21. Minneapolis, Minnesota
  22. Chesterfield, Missouri
  23. Florissant, Missouri
  24. Omaha, Nebraska
  25. Henderson, Nevada
  26. Henderson, Nevada
  27. Belvidere, New Jersey
  28. Bridgewater, New Jersey
  29. Clifton, New Jersey
  30. Elizabeth, New Jersey
  31. Hillsborough, New Jersey
  32. Trenton, New Jersey
  33. Brooklyn, New York
  34. Buffalo, New York
  35. Cincinnati, Ohio
  36. Cincinnati, Ohio
  37. Oklahoma City, Oklahoma
  38. Tulsa, Oklahoma
  39. Bensalem, Pennsylvania
  40. Lansdale, Pennsylvania
  41. Philadelphia, Pennsylvania
  42. Providence, Rhode Island
  43. Goose Creek, South Carolina
  44. Mount Pleasant, South Carolina
  45. Bristol, Tennessee
  46. Kingsport, Tennessee
  47. Dallas, Texas
  48. Houston, Texas
  49. Plano, Texas
  50. San Antonio, Texas
  51. Chesapeake, Virginia
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
Official Title  ICMJE A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed to Evaluate the Efficacy of an Aggressive Multi-Risk Factor Management Strategy With Caduet (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensive Subjects With Additional Risk Factors.
Brief Summary The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dyslipidemia
  • Hypertension
Intervention  ICMJE
  • Drug: Amlodipine besylate
    Amlodipine besylate 5 mg
  • Drug: Amlodipine besylate/atorvastatin calcium single pill combination
    Amlodipine/atorvastatin single pill combination 10/20 mg
  • Drug: Amlodipine besylate
    Amlodipine besylate 10 mg
  • Drug: Amlodipine besylate/atorvastatin calcium single pill combination
    Amlodipine/atorvastatin single pill combination 5/20 mg
Study Arms  ICMJE
  • Active Comparator: Norvasc 5 mg
    Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.
    Intervention: Drug: Amlodipine besylate
  • Experimental: Caduet 10/20mg
    Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.
    Intervention: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
  • Active Comparator: Norvasc 10 mg
    Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.
    Intervention: Drug: Amlodipine besylate
  • Experimental: Caduet 5/20mg
    Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .
    Intervention: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
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
Actual Enrollment  ICMJE
 (submitted: November 26, 2008)
245
Original Enrollment  ICMJE
 (submitted: December 13, 2006)
260
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Exclusion Criteria:

  • Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
  • Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
  • Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)
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 NCT00412113
Other Study ID Numbers  ICMJE A3841045
Has Data Monitoring Committee No
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 2009

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