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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
135
placebo, oral, tablets, once daily, for 28 days
PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days
PF-00489791 4 mg, oral, tablets, once daily, for 28 days
National Research Institute
Los Angeles, California, United States
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28
The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean daytime SBP was an average of SBP measurements taken between 08:00 and 16:00 hours by ABPM device on the specified time points. In this outcome measure change from baseline in mean daytime SBP at Day 28 is reported.
Time frame: 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
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) as Measured by ABPM at Day 28
The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean daytime DBP was an average of DBP measurements taken between 08:00 and 16:00 hours by ABPM device on the specified time points. In this outcome measure change from baseline in mean daytime DBP at Day 28 is reported.
Time frame: 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
Change From Baseline in Mean 24-Hour SBP and DBP as Measured by ABPM at Day 28
The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean 24-hour SBP and DBP was an average of SBP and DBP measurements, respectively, taken for 24 hours by ABPM device respectively. In this outcome measure change from baseline in mean 24-hour SBP and DBP at Day 28 is reported.
Time frame: Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28
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PF-00489791 10 mg, oral, tablets, once daily, for 28 days
Apex Research Institute
Santa Ana, California, United States
Orange County Research Center
Tustin, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Andres Patron, DO, PA
Pembroke Pines, Florida, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States
Riser Medical Associates
Picayune, Mississippi, United States
...and 10 more locations
Minimum and Maximum SBP and DBP as Measured by ABPM Over 24 Hours on Baseline, Day 1, 14 and 28
The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed on Baseline, Day 1, 14 and 28. In this outcome measure maximum and minimum SBP and DBP values recorded by ABPM device over 24 hours on Baseline, Day 1, 14 and 28 are reported.
Time frame: Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug), Day 1, 14 and 28
Change From Baseline in Cuff SBP and DBP at Day 28
At Baseline and Day 28 visit, sitting cuff SBP and DBP was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the first BP was obtained. The BP measurement was done in duplicate approximately 5 minutes apart. The mean of duplicate measurements was recorded.
Time frame: Baseline (pre dose value on Day 1 of treatment), Day 28
Change From Baseline in Cuff SBP and DBP at Day 31
At Baseline and Day 31 visit, sitting cuff SBP and DBP was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the first BP was obtained. The BP measurement was done in duplicate approximately 5 minutes apart. The mean of duplicate measurements was recorded.
Time frame: Baseline (pre dose value on Day 1 of treatment), Day 31
Change From Baseline in Cuff Mean Arterial Pressure (MAP) at Day 28
At Baseline and Day 28, sitting cuff MAP was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the first MAP was obtained. The MAP measurement was done in duplicate approximately 5 minutes apart. The mean of duplicate measurements was recorded.
Time frame: Baseline (pre dose value on Day 1 of treatment), Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Time frame: Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)
Number of Participants With Clinically Significant Laboratory Abnormalities
Criteria for laboratory abnormalities included: hemoglobin, hematocrit, red blood cell count, total neutrophils, total protein, albumin: \<0.8\* limit of normal (LLN). Platelets: less than (\<)0.5\* LLN, greater than (\>)1.75\* upper limit of normal (ULN); white blood cell, glucose: \<0.6\*LLN, \>1.5\*ULN, lymphocytes: \<0.8\*LLN; \>1.2\*ULN; basophils, monocytes, eosinophils, total protein, albumin, uric acid: \>1.2\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; blood urea nitrogen, creatinine: \>1.3\*ULN; sodium: \<0.95\*LLN, \>1.05\*ULN; potassium, chloride, calcium: \<0.9\*LLN, \>1.1\*ULN; creatine kinase: \> 2.0\*ULN, \> 3.0\*ULN, \>10.0\*ULN; total bilirubin, direct bilirubin, indirect bilirubin:\>1.5\*ULN; urinalysis: urine pH: \<4.5, \>8, glucose, ketones, protein, blood/hemoglobin: \>=1, RBC, WBC, epithelial cells: \>=6, casts: \>1, bacteria: \>20.
Time frame: Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)
Change From Baseline in Heart Rate at Baseline, Day 1, 7, 14, 21, 28 and 31
Sitting heart rate was measured with the participant's arm supported at the level of the heart. The participant sat with feet flat on the floor for 5 minutes before the heart rate was measured. The heart rate was measured for a minimum of 30 seconds, and the average of two measurements was recorded. Heart rate was measured in beats per minute.
Time frame: Baseline (pre dose value on Day 1 of treatment), Day 1, 7, 14, 21, 28, 31
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Following ECG parameters were evaluated: QT interval, QTc interval, RR interval, PR interval, QRS complex and heart rate. Clinical significant ECG findings were determined by the investigator's discretion.
Time frame: Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)