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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PF-00489791 20 mg titrated to 40 mg | Experimental |
| |
| PF-00489791 4 mg | Experimental |
| |
| PF-00489791 10 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | placebo, oral, tablets, once daily, for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Institute | Los Angeles | California | 90057 | United States | ||
| Apex Research Institute |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 426 participants were screened, of whom 291 participants were screen failed and 135 participants were enrolled in the study and assigned to study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| FG001 | PF-00489791 4 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PF-00489791 |
| Drug |
PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days |
|
| PF-00489791 | Drug | PF-00489791 4 mg, oral, tablets, once daily, for 28 days |
|
| PF-00489791 | Drug | PF-00489791 10 mg, oral, tablets, once daily, for 28 days |
|
| 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. | Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 1 up to 14 days after last dose of study drug (maximum up to 42 days) |
| Santa Ana |
| California |
| 92705 |
| United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| University of Connecticut Health Center | Farmington | Connecticut | 06030-3940 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Andres Patron, DO, PA | Pembroke Pines | Florida | 33026 | United States |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | United States |
| Twin Cities Clinical Research | Brooklyn Center | Minnesota | 55430 | United States |
| Riser Medical Associates | Picayune | Mississippi | 39466 | United States |
| Midwest Internists Clinical Research, P.C. | St Louis | Missouri | 63141 | United States |
| Triangle Medical Research Associates, LLC | Cary | North Carolina | 27518 | United States |
| Medical Research Associates of Charlotte, Inc | Charlotte | North Carolina | 28277 | United States |
| Triangle Medical Research Associates | Raleigh | North Carolina | 27609 | United States |
| Triangle Medical Research | Raleigh | North Carolina | 27609 | United States |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | United States |
| Sterling Research Group limited | Cincinnati | Ohio | 45246 | United States |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | United States |
| Clinical Research Associates Incorporated | Nashville | Tennessee | 37203 | United States |
Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 milligram (mg) (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose.
| FG002 | PF-00489791 10 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| FG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
| Treated |
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| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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|
Safety analysis set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| BG001 | PF-00489791 4 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| BG002 | PF-00489791 10 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| BG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | millimeter of mercury | 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 |
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| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | millimeter of mercury | 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 |
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| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | millimeter of mercury | 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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| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "number analyzed" signifies participants evaluable at specified time points. | Posted | Mean | Standard Deviation | millimeter of mercury | Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug), Day 1, 14 and 28 |
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| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | millimeter of mercury | Baseline (pre dose value on Day 1 of treatment), Day 28 |
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| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimeter of mercury | Baseline (pre dose value on Day 1 of treatment), Day 31 |
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| Secondary | 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. | FAS included all randomized participants who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | millimeter of mercury | Baseline (pre dose value on Day 1 of treatment), Day 28 |
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| Secondary | 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. | Safety analysis set included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to 14 days after last dose of study drug (maximum up to 42 days) |
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| Secondary | 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. | Safety analysis set included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to 14 days after last dose of study drug (maximum up to 42 days) |
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| Secondary | 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. | FAS included all randomized subjects who received at least 1 dose of study medication and had a valid baseline and at least 1 valid post-baseline assessment of the primary endpoint. Here, "number analyzed" signifies participants evaluable at specific time points. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (pre dose value on Day 1 of treatment), Day 1, 7, 14, 21, 28, 31 |
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| Secondary | 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. | Safety analysis set included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to 14 days after last dose of study drug (maximum up to 42 days) |
|
Day 1 up to 14 days after last dose of study drug (maximum up to 42 days)
Same event may appear as both an adverse events (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants with mild to moderate hypertension were randomized to receive placebo orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. | 0 | 34 | 1 | 34 | 12 | 34 |
| EG001 | PF-00489791 4 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 4 mg (2 tablets of 2 mg) orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. | 0 | 34 | 1 | 34 | 11 | 34 |
| EG002 | PF-00489791 10 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. | 0 | 32 | 0 | 32 | 11 | 32 |
| EG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. | 0 | 33 | 0 | 33 | 13 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Mucous stools | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
| |
| Viral labyrinthitis | Infections and infestations | MedDRA v10.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v10.1 | Non-systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA v10.1 | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Libido increased | Psychiatric disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Erection increased | Reproductive system and breast disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Spontaneous penile erection | Reproductive system and breast disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA v10.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v10.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000619499 | PF-00489791 |
Not provided
Not provided
Not provided
| 45-64 years |
|
| Greater than or equal to (>=) 65 years |
|
| Male |
|
| 0.0170 |
| LS mean difference |
| -4.66 |
| Standard Error of the Mean |
| 1.92 |
| 2-Sided |
| 95 |
| -8.47 |
| -0.85 |
| Superiority |
| Nonlinear dose response regression model | 0.0026 | LS mean difference | -6.97 | Standard Error of the Mean | 2.26 | 2-Sided | 95 | -11.45 | -2.48 | Superiority |
| OG002 | PF-00489791 10 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
|
|
| OG002 | PF-00489791 10 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
|
|
| OG002 |
| PF-00489791 10 mg |
Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
|
Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
|
|
Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
|
Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
|
|
| OG002 | PF-00489791 10 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
|
| OG002 | PF-00489791 10 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
|
Participants with mild to moderate hypertension were randomized to receive PF-00489791 10 mg tablet orally, once daily for 28 days. Participants were followed up to maximum of 14 days after the last dose. |
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
|
| OG003 | PF-00489791 20/40 mg | Participants with mild to moderate hypertension were randomized to receive PF-00489791 20 mg (2 tablets of 10 mg) orally, once daily for 14 days and then 40 mg (4 tablets of 10 mg) orally once daily for next 14 days. Participants were followed up to maximum of 14 days after the last dose. |
|
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