Clinical trial NCT00422461: A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Clinical Trial
Randomized Controlled Trial
Humans
Cyclic Nucleotide Phosphodiesterases Type 5
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28
timeFrame: From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28
Secondary outcomes:
measure: Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) as Measured by ABPM at Day 28
timeFrame: From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28
measure: Change From Baseline in Mean 24-Hour SBP and DBP as Measured by ABPM at Day 28
timeFrame: Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28
measure: Minimum and Maximum SBP and DBP as Measured by ABPM Over 24 Hours on Baseline, Day 1, 14 and 28
timeFrame: Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug), Day 1, 14 and 28
measure: Change From Baseline in Cuff SBP and DBP at Day 28
timeFrame: Baseline (pre dose value on Day 1 of treatment), Day 28
measure: Change From Baseline in Cuff SBP and DBP at Day 31
timeFrame: Baseline (pre dose value on Day 1 of treatment), Day 31
measure: Change From Baseline in Cuff Mean Arterial Pressure (MAP) at Day 28
timeFrame: Baseline (pre dose value on Day 1 of treatment), Day 28
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)
measure: Change From Baseline in Heart Rate at Baseline, Day 1, 7, 14, 21, 28 and 31
timeFrame: Baseline (pre dose value on Day 1 of treatment), Day 1, 7, 14, 21, 28, 31
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron, DO, PA
state: Florida
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Brooklyn Center
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Picayune
country: United States
facility: Riser Medical Associates
state: Mississippi
city: Saint Louis
country: United States
facility: Midwest Internists Clinical Research, P.C.
state: Missouri
city: Cary
country: United States
facility: Triangle Medical Research Associates, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Medical Research Associates of Charlotte, Inc
state: North Carolina
city: Raleigh
country: United States
facility: Triangle Medical Research Associates
state: North Carolina
city: Raleigh
country: United States
facility: Triangle Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group limited
state: Ohio
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates Incorporated
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: