A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure

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NCT00422461

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Study Location
Pfizer Investigational Site
Los Angeles, California, 90057, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
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

1. Males and/or Females of non-childbearing potential between 18 and 70 years of age

2. History of mild to moderate hypertension

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


1. Type 1 or 2 diabetes on prescribed medications


2. Secondary, severe, or malignant hypertension


3. History of a significant cardiovascular event within the last 12 months of enrollment

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure
Official Title  ICMJE A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study Of PF-00489791 In Subjects With Stage 1 And 2 Essential Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)
Brief Summary The purpose of this study is to evaluate the safety and blood pressure lowering effect of different doses of PF-00489791 in patients with mild to moderate high blood pressure
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: PF-00489791
    PF-00489791 4 mg, oral, tablets, once daily, for 28 days
  • Drug: PF-00489791
    PF-00489791 10 mg, oral, tablets, once daily, for 28 days
  • Drug: PF-00489791
    PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days
  • Drug: placebo
    placebo, oral, tablets, once daily, for 28 days
Study Arms  ICMJE
  • Experimental: PF-00489791 4 mg
    Intervention: Drug: PF-00489791
  • Experimental: PF-00489791 10 mg
    Intervention: Drug: PF-00489791
  • Experimental: PF-00489791 20 mg titrated to 40 mg
    Intervention: Drug: PF-00489791
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
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
Estimated Enrollment  ICMJE
 (submitted: January 12, 2007)		140
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and/or Females of non-childbearing potential between 18 and 70 years of age
  2. History of mild to moderate hypertension

Exclusion Criteria:

  1. Type 1 or 2 diabetes on prescribed medications
  2. Secondary, severe, or malignant hypertension
  3. History of a significant cardiovascular event within the last 12 months of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00422461
Other Study ID Numbers  ICMJE A7331007
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
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2009

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