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

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ClinicalTrials.gov Identifier: NCT00422461
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : October 12, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 12, 2007
First Posted Date  ICMJE January 17, 2007
Last Update Posted Date October 12, 2009
Study Start Date  ICMJE February 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • The mean daytime systolic blood pressure lowering effect of PF-00489791 using Ambulatory Blood Pressure Monitoring (ABPM) as compared to placebo [ Time Frame: 4 weeks ]
  • The safety, tolerability and effective dose-range of PF-00489791 [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2007)
  • To evaluate the daytime lowering blood pressure effect of PF-00489791 using Ambulatory Blood Pressure Monitoring as compared to placebo on systolic blood pressure.
  • To evaluate the safety, tolerability and dose-range effect of PF-00489791.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • The mean daytime diastolic blood pressure lowering effect of PF-00489791 using Ambulatory Blood Pressure Monitoring (ABPM) as compared to placebo [ Time Frame: 4 weeks ]
  • The mean change from baseline in cuff systolic, diastolic and mean arterial blood pressure [ Time Frame: 4 weeks ]
  • The mean change from baseline in 24 hour systolic and diastolic blood pressure measured by ABPM [ Time Frame: 4 weeks ]
  • The relationships between plasma concentration of PF-00489791 and change in systolic blood pressure, diastolic blood pressure and heart rate [ Time Frame: 4 weeks ]
  • The minimum and maximum decrease in systolic and diastolic blood pressure measured by ABPM [ Time Frame: 4 weeks ]
  • The effect of PF-00489791 on pulse pressure [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2007)
  • To evaluate the daytime lowering blood pressure effect of PF-00489791 using Ambulatory Blood Pressure Monitoring as compared to placebo on diastolic blood pressure.
  • To evaluate mean change from baseline in seated systolic blood pressure.
  • To evaluate change from baseline in 24 hour systolic and diastolic blood pressure.
  • To evaluate relationships between plasma concentration of study medication and change in systolic, diastolic blood pressure and heart rate.
  • To evaluate the effect of study medication on pulse pressure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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