Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension

NCT00355589

Last updated date
Study Location
Cahaba Research Inc.
Birmingham, Alabama, 35242, 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.
Hypertension, High Blood Pressure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.

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


- Inability to discontinue all prior antihypertensive medications


- Heart failure


- History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal
heart rhythm


- Liver or kidney disease


- Certain drugs used to treat other conditions like an enlarged prostate gland, or
arthritis


- Allergy or reactions to certain medications used to treat high blood pressure


Other protocol-defined inclusion and exclusion criteria apply.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Hypertension, High Blood PressureRamipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension NCT00355589
  1. Birmingham, Alabama
  2. Huntsville, Alabama
  3. Glendale, Arizona
  4. Beverly Hills, California
  5. Beverly Hills, California
  6. Buena Park, California
  7. Greenbrae, California
  8. Long Beach, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Roseville, California
  12. Studio City, California
  13. Temecula, California
  14. Farmington, Connecticut
  15. Clearwater, Florida
  16. Coral Gables, Florida
  17. Deland, Florida
  18. Hollywood, Florida
  19. Largo, Florida
  20. Miami, Florida
  21. Miami, Florida
  22. New Port Richey, Florida
  23. Ocala, Florida
  24. Palm Harbor, Florida
  25. Pembroke Pines, Florida
  26. Sarasota, Florida
  27. West Palm Beach, Florida
  28. Atlanta, Georgia
  29. Chicago, Illinois
  30. Chicago, Illinois
  31. Gurnee, Illinois
  32. Indianapolis, Indiana
  33. Livonia, Michigan
  34. Traverse City, Michigan
  35. Brooklyn Center, Minnesota
  36. Las Vegas, Nevada
  37. Voorhees, New Jersey
  38. Fayetteville, North Carolina
  39. Hickory, North Carolina
  40. Raleigh, North Carolina
  41. Statesville, North Carolina
  42. Winston-Salem, North Carolina
  43. Winston-Salem, North Carolina
  44. Cincinnati, Ohio
  45. Marion, Ohio
  46. Mogadore, Ohio
  47. Norman, Oklahoma
  48. Medford, Oregon
  49. Philadelphia, Pennsylvania
  50. Charleston, South Carolina
  51. Columbia, South Carolina
  52. Greer, South Carolina
  53. Austin, Texas
  54. Carrollton, Texas
  55. Dallas, Texas
  56. San Antonio, Texas
  57. San Antonio, Texas
  58. Norfolk, Virginia
  59. Virginia Beach, Virginia
  60. Lakewood, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension
Official Title  ICMJE A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Efficacy and Safety of a Combination of Ramipril Plus Hydrochlorothiazide Versus the Component Monotherapies in Subjects With Essential Hypertension
Brief Summary The purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.
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
  • Hypertension
  • Blood Pressure, High
Intervention  ICMJE Drug: Ramipril and hydrochlorothiazide
Study Arms  ICMJE Not Provided
Publications * White WB, Cleveland JM, Rolleri RL; Ramipril-Hydrochlorothiazide Study Group. Utility of semiautomatic clinic and 24-h ambulatory blood pressure measurements to evaluate combination therapy: the Ramipril-Hydrochlorothiazide Hypertension trial. J Hum Hypertens. 2008 Aug;22(8):559-68. doi: 10.1038/jhh.2008.26. Epub 2008 May 8.

*   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 Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.

Exclusion Criteria:

  • Inability to discontinue all prior antihypertensive medications
  • Heart failure
  • History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm
  • Liver or kidney disease
  • Certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis
  • Allergy or reactions to certain medications used to treat high blood pressure

Other protocol-defined inclusion and exclusion criteria apply.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00355589
Other Study ID Numbers  ICMJE K749-06-3001
B5051001 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pfizer
Verification Date October 2012

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