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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00422461
First received: January 12, 2007
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: PF-00489791
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The safety, tolerability and effective dose-range of PF-00489791 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The mean change from baseline in cuff systolic, diastolic and mean arterial blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The mean change from baseline in 24 hour systolic and diastolic blood pressure measured by ABPM [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The relationships between plasma concentration of PF-00489791 and change in systolic blood pressure, diastolic blood pressure and heart rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The minimum and maximum decrease in systolic and diastolic blood pressure measured by ABPM [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The effect of PF-00489791 on pulse pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: February 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00489791 4 mg Drug: PF-00489791
PF-00489791 4 mg, oral, tablets, once daily, for 28 days
Experimental: PF-00489791 10 mg Drug: PF-00489791
PF-00489791 10 mg, oral, tablets, once daily, for 28 days
Experimental: PF-00489791 20 mg titrated to 40 mg Drug: PF-00489791
PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days
Placebo Comparator: Placebo Drug: placebo
placebo, oral, tablets, once daily, for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422461

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90057
Pfizer Investigational Site
Santa Ana, California, United States, 92705
Pfizer Investigational Site
Tustin, California, United States, 92780
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States, 06030-3940
Pfizer Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33026
United States, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Minnesota
Pfizer Investigational Site
Brooklyn Center, Minnesota, United States, 55430
United States, Mississippi
Pfizer Investigational Site
Picayune, Mississippi, United States, 39466
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, North Carolina
Pfizer Investigational Site
Cary, North Carolina, United States, 27518
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28277
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27609
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45246
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37920
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00422461     History of Changes
Other Study ID Numbers: A7331007
Study First Received: January 12, 2007
Last Updated: October 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Clinical Trial, Randomized Controlled Trial, Humans, Cyclic Nucleotide Phosphodiesterases Type 5

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014