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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422461
First Posted: January 17, 2007
Last Update Posted: October 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)

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 ]
  • The safety, tolerability and effective dose-range of PF-00489791 [ Time Frame: 4 weeks ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00422461     History of Changes
Other Study ID Numbers: A7331007
First Submitted: January 12, 2007
First Posted: January 17, 2007
Last Update Posted: October 12, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases