A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00422461
First received: January 12, 2007
Last updated: October 7, 2009
Last verified: October 2009
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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:
- Males and/or Females of non-childbearing potential between 18 and 70 years of age
- History of mild to moderate hypertension
Exclusion Criteria:
- Type 1 or 2 diabetes on prescribed medications
- Secondary, severe, or malignant hypertension
- 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 May 16, 2013