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B7911002 was prematurely discontinued due to a safety concern that led to decision to terminate the study on 10 Nov 2014
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The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid in subjects suffering from gout following 14 days of dosing, as well as assessing safety and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06743649 dose level 1 (Cohort 1) | Experimental |
| |
| Placebo for PF-06743649 (Cohort 1) | Placebo Comparator |
| |
| PF-06743649 dose level 2 (Cohort 2) | Experimental |
| |
| Placebo for PF-06743649 (Cohort 2) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06743649 | Drug | Daily dosing (dose level 1) tablet for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline of Serum Uric Acid | An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout. | Baseline (pre-dose Day 1) |
| Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14 | Day 14 Hour 24 | |
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An 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 are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state AEs included both serious and non-serious events. | Baseline up to 28 days after last study drug administration (Day 42) |
| Number of Participants With Laboratory Test Abnormalities | Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up | Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29) | |
| Number of Participants Reaching Serum Uric Acid Levels <6, <5 and <4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14 |
Not provided
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 |
|---|---|---|---|---|---|---|
| MRA Clinical Research, LLC | Miami | Florida | 33143 | United States | ||
| Miami Research Associates, Inc. |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: PF-06743649 2.5 mg to 10 mg | Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days. |
| FG001 | Cohort 1: PF-06743649 40 mg | Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days. |
| FG002 | Cohort 2: PF-06743649 5 mg | Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant. |
| FG003 | Cohort 1 and 2: Placebo | Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: PF-06743649 2.5 mg to 10 mg | Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days. |
| BG001 | Cohort 1: PF-06743649 40 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Baseline of Serum Uric Acid | An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout. | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. | Posted | Mean | Standard Deviation | milligram per deciliter(mg/dL) | Baseline (pre-dose Day 1) |
|
Baseline up to 28 days after last study drug administration.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: PF-06743649 2.5 mg to 10 mg | Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal injury | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 17.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
Not provided
Not provided
Not provided
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| Placebo |
| Other |
Daily dosing (tablet) for 14 days |
|
| PF-06743649 | Drug | Daily dosing (dose level 2) tablet(s) for 14 days |
|
| Placebo | Other | Daily dosing (tablets) for 14 days |
|
| Baseline up to follow up visit (Day 25-29) |
| Number of Participants With Potentially Clinically Significant Vital Signs Findings | Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg) or more than or equal to (>=)30 mmHg change from baseline, diastolic BP of <50 mmHg or >=20 mmHg change from baseline, Supine pulse rate of <40 or more than (>)120 beats per minute (bpm). | Baseline up to follow up visit (Day 25-29) |
| Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria | Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) or increase from baseline >=25% when baseline >200 msec or increase from baseline >=50% when baseline less than or equal to (<=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec or >=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to < 480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec from baseline. | Baseline up to Day 16 |
Number of participants reaching serum uric acid levels <6, <5 and <4 mg/dL at 7 and 14 days after initiation.
| 24 hours post dose on Day 7 and Day 14 |
| Incidence and Severity of Gout Flare Attacks | Baseline up to Day 42 |
| Duration of Gout Flare Attacks | Duration of gout flare attacks with participants who developed gout flare attacks. | Baseline up to Day 42 |
| Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14 | Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL). | 0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14 |
| Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14 | PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL). | Day 1, Day 7, and Day 14 |
| Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up | Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo. | Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29) |
| Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up | Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29) |
| Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14 | Change from baseline in urinary uric acid cumulative amounts. | Baseline, Day 1, Day 7 and Day 14 |
| Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14 | Change from baseline in urinary xanthine cumulative amounts. | Baseline, Day 1, Day 7 and Day 14 |
| Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14 | Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14 | Baseline, Day 1, Day 7 and Day 14 |
| South Miami |
| Florida |
| 33143 |
| United States |
| Vince and Associates Clinical Research Inc. | Overland Park | Kansas | 66211 | United States |
| Vince and Associates Clinical Research, Inc. | Overland Park | Kansas | 66212 | United States |
| Study Terminated by Sponsor |
|
| Withdrawal by Subject |
|
Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days. |
| BG002 | Cohort 2: PF-06743649 5 mg | Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant. |
| BG003 | Cohort 1 and 2: Placebo | Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Cohort 2: PF-06743649 5 mg | Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant. |
| OG003 | Cohort 1 and 2: Placebo | Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons. |
|
|
| Primary | Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14 | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. Number of participants analyzed is number of evaluable participants for this outcome measure. No data due to "Cohort 2: PF-06743649 5 mg" termination after 2 days of dosing. | Posted | Mean | Standard Deviation | percent (%) | Day 14 Hour 24 |
|
|
|
|
| Primary | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An 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 are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state AEs included both serious and non-serious events. | The safety analysis population included all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 28 days after last study drug administration (Day 42) |
|
|
|
| Primary | Number of Participants With Laboratory Test Abnormalities | Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen). | The safety analysis population included all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to follow up visit (Day 25-29) |
|
|
|
| Primary | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg) or more than or equal to (>=)30 mmHg change from baseline, diastolic BP of <50 mmHg or >=20 mmHg change from baseline, Supine pulse rate of <40 or more than (>)120 beats per minute (bpm). | The safety analysis population included all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to follow up visit (Day 25-29) |
|
|
|
| Primary | Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria | Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) or increase from baseline >=25% when baseline >200 msec or increase from baseline >=50% when baseline less than or equal to (<=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec or >=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to < 480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec from baseline. | The safety analysis population included all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Day 16 |
|
|
|
| Secondary | Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm. | Posted | Mean | Standard Deviation | mg/dL | Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29) |
|
|
|
|
| Secondary | Number of Participants Reaching Serum Uric Acid Levels <6, <5 and <4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14 | Number of participants reaching serum uric acid levels <6, <5 and <4 mg/dL at 7 and 14 days after initiation. | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. | Posted | Number | participants | 24 hours post dose on Day 7 and Day 14 |
|
|
|
| Secondary | Incidence and Severity of Gout Flare Attacks | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. | Posted | Number | participants | Baseline up to Day 42 |
|
|
|
| Secondary | Duration of Gout Flare Attacks | Duration of gout flare attacks with participants who developed gout flare attacks. | Participants who developed gout flare attacks (Duration was not assessed as no participant developed gout flare attacks). | Posted | Baseline up to Day 42 |
|
|
| Secondary | Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14 | Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL). | All participants randomized and treated who have at least 1 measureable concentration; n=number of participants analyzed in each respective arm. | Posted | Mean | Standard Deviation | ng/mL | 0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14 |
|
|
|
| Secondary | Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14 | PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL). | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm. | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 7, and Day 14 |
|
|
|
| Secondary | Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up | Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo. | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29) |
|
|
|
|
| Secondary | Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm. | Posted | Mean | Standard Deviation | mcg/mL | Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29) |
|
|
|
|
| Secondary | Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14 | Change from baseline in urinary uric acid cumulative amounts. | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm. | Posted | Mean | Standard Deviation | mg | Baseline, Day 1, Day 7 and Day 14 |
|
|
|
|
| Secondary | Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14 | Change from baseline in urinary xanthine cumulative amounts. | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm. | Posted | Mean | Standard Deviation | mg | Baseline, Day 1, Day 7 and Day 14 |
|
|
|
|
| Secondary | Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14 | Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14 | The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm. | Posted | Mean | Standard Deviation | mg | Baseline, Day 1, Day 7 and Day 14 |
|
|
|
|
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Cohort 1: PF-06743649 40 mg | Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days. | 0 | 3 | 3 | 3 |
| EG002 | Cohort 2: PF-06743649 5 mg | Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant. | 1 | 11 | 2 | 11 |
| EG003 | Cohort 1 and 2: Placebo | Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons. | 0 | 9 | 4 | 9 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Cystatin C increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 17.1 | 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.
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Mean Difference (Final Values) |
| -66.310 |
| 2-Sided |
| 90 |
| -71.310 |
| -61.540 |
| No |
| Superiority or Other |
| Participants with SAEs |
|
| Supine Diastolic BP (mmHg) <50 |
|
| Supine Pulse Rate (bpm) <40 |
|
| Supine Pulse Rate (bpm) >120 |
|
| Increase Supine Systolic BP (mmHg) >=30 |
|
| Increase Supine Diastolic BP (mmHg) >=20 |
|
| Decrease Supine Systolic BP (mmHg) >=30 |
|
| Decrease Supine Diastolic BP (mmHg) >=20 |
|
| QRS complex (msec) >=140 |
|
| QTCF (msec) 450-<480 |
|
| QTCF (msec) 480-<500 |
|
| QTCF (msec) >=500 |
|
| PR increase from baseline >=25/50% |
|
| QRS complex increase from baseline >=50% |
|
| QTCF increase from baseline 30 to <60 msec |
|
| QTCF increase from baseline >=60 msec |
|
| Day 1, Hour 1 (n=6,3,11, 9) |
|
| Day 1, Hour 2 (n=7,3,11,9) |
|
| Day 1, Hour 4 (n=7,3,11,9) |
|
| Day 1, Hour 8 (n=7,3,11,9) |
|
| Day 1, Hour 12 (n=7,3,11,9) |
|
| Day 1, Hour 24 (n=7,3,11,9) |
|
| Day 3 (n=7,3,10,9) |
|
| Day 7, pre-dose (n=7,2,0,6) |
|
| Day 7, Hour 1 (n=7,2,0,6) |
|
| Day 7, Hour 2 (n=7,2,0,6) |
|
| Day 7, Hour 4 (n=7,2,0,6) |
|
| Day 7, Hour 8 (n=7,2,0,6) |
|
| Day 7, Hour 12 (n=7,2,0,6) |
|
| Day 7, Hour 24 (n=7,2,0,6) |
|
| Day 11 (n=6,2,0,6) |
|
| Day 14, pre-dose (n=6,2,0,6) |
|
| Day 14, Hour 1 (n=6,2,0,6) |
|
| Day 14, Hour 2 (n=6,2,0,6) |
|
| Day 14, Hour 4 (n=6,2,0,6) |
|
| Day 14, Hour 8 (n=6,2,0,6) |
|
| Day 14, Hour 12 (n=6,2,0,6) |
|
| Day 14, Hour 24 (n=6,2,0,6) |
|
| Follow-up (Day 25-29) (n=6,3,10,9) |
|
| LS Mean Difference |
| -0.62 |
| Standard Error of the Mean |
| 0.19 |
| 2-Sided |
| 90 |
| -0.95 |
| -0.28 |
| No |
| Superiority or Other |
| Day 1, Hour 4 | Mixed Models Analysis | LS Mean Difference | -1.34 | Standard Error of the Mean | 0.10 | 2-Sided | 90 | -1.52 | -1.16 | No | Superiority or Other |
| Day 1, Hour 8 | Mixed Models Analysis | LS Mean Difference | -1.86 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | -2.38 | -1.33 | No | Superiority or Other |
| Day 1, Hour 12 | Mixed Models Analysis | LS Mean Difference | -1.83 | Standard Error of the Mean | 0.19 | 2-Sided | 90 | -2.18 | -1.48 | No | Superiority or Other |
| Day 1, Hour 24 | Mixed Models Analysis | LS Mean Difference | -1.74 | Standard Error of the Mean | 0.20 | 2-Sided | 90 | -2.11 | -1.37 | No | Superiority or Other |
| Day 3 | Mixed Models Analysis | LS Mean Difference | -2.48 | Standard Error of the Mean | 0.23 | 2-Sided | 90 | -2.89 | -2.06 | No | Superiority or Other |
| Day 7, pre-dose | Mixed Models Analysis | LS Mean Difference | -2.75 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | -3.29 | -2.20 | No | Superiority or Other |
| Day 7, Hour 1 | Mixed Models Analysis | LS Mean Difference | -2.80 | Standard Error of the Mean | 0.33 | 2-Sided | 90 | -3.39 | -2.21 | No | Superiority or Other |
| Day 7, Hour 2 | Mixed Models Analysis | LS Mean Difference | -3.06 | Standard Error of the Mean | 0.36 | 2-Sided | 90 | -3.72 | -2.41 | No | Superiority or Other |
| Day7, Hour 4 | Mixed Models Analysis | LS Mean Difference | -3.40 | Standard Error of the Mean | 0.35 | 2-Sided | 90 | -4.03 | -2.77 | No | Superiority or Other |
| Day 7, Hour 8 | Mixed Models Analysis | LS Mean Difference | -3.30 | Standard Error of the Mean | 0.28 | 2-Sided | 90 | -3.82 | -2.79 | No | Superiority or Other |
| Day 7, Hour 12 | Mixed Models Analysis | LS Mean Difference | -3.20 | Standard Error of the Mean | 0.28 | 2-Sided | 90 | -3.72 | -2.68 | No | Superiority or Other |
| Day 7, Hour 24 | Mixed Models Analysis | LS Mean Difference | -2.81 | Standard Error of the Mean | 0.27 | 2-Sided | 90 | -3.30 | -2.32 | No | Superiority or Other |
| Day 11 | Mixed Models Analysis | LS Mean Difference | -4.56 | Standard Error of the Mean | 0.35 | 2-Sided | 90 | -5.19 | -3.92 | No | Superiority or Other |
| Day 14, pre-dose | Mixed Models Analysis | LS Mean Difference | -4.32 | Standard Error of the Mean | 0.23 | 2-Sided | 90 | -4.75 | -3.88 | No | Superiority or Other |
| Day 14, Hour 1 | Mixed Models Analysis | LS Mean Difference | -4.55 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | -5.02 | -4.08 | No | Superiority or Other |
| Day 14, Hour 2 | Mixed Models Analysis | LS Mean Difference | -4.97 | Standard Error of the Mean | 0.27 | 2-Sided | 90 | -5.47 | -4.47 | No | Superiority or Other |
| Day 14, Hour 4 | Mixed Models Analysis | LS Mean Difference | -5.43 | Standard Error of the Mean | 0.22 | 2-Sided | 90 | -5.83 | -5.02 | No | Superiority or Other |
| Day 14, Hour 8 | Mixed Models Analysis | LS Mean Difference | -5.57 | Standard Error of the Mean | 0.28 | 2-Sided | 90 | -6.08 | -5.05 | No | Superiority or Other |
| Day 14, Hour 12 | Mixed Models Analysis | LS Mean Difference | -5.34 | Standard Error of the Mean | 0.28 | 2-Sided | 90 | -5.86 | -4.82 | No | Superiority or Other |
| Day 14, Hour 24 | Mixed Models Analysis | LS Mean Difference | -4.65 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | -5.12 | -4.18 | No | Superiority or Other |
| Follow-up, Day 25-29 | Mixed Models Analysis | LS Mean Difference | -1.09 | Standard Error of the Mean | 1.03 | 2-Sided | 90 | -2.97 | 0.79 | No | Superiority or Other |
| Day 1, Hour 1 | Mixed Models Analysis | LS Mean Difference | -0.62 | Standard Error of the Mean | 0.17 | 2-Sided | 90 | -0.92 | -0.32 | No | Superiority or Other |
| Day 1, Hour 2 | Mixed Models Analysis | LS Mean Difference | -1.18 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | -1.61 | -0.75 | No | Superiority or Other |
| Day 1, Hour 4 | Mixed Models Analysis | LS Mean Difference | -2.91 | Standard Error of the Mean | 0.12 | 2-Sided | 90 | -3.14 | -2.69 | No | Superiority or Other |
| Day 1, Hour 8 | Mixed Models Analysis | LS Mean Difference | -3.70 | Standard Error of the Mean | 0.37 | 2-Sided | 90 | -4.36 | -3.03 | No | Superiority or Other |
| Day 1, Hour 12 | Mixed Models Analysis | LS Mean Difference | -3.84 | Standard Error of the Mean | 0.24 | 2-Sided | 90 | -4.28 | -3.40 | No | Superiority or Other |
| Day 1, Hour 24 | Mixed Models Analysis | LS Mean Difference | -3.47 | Standard Error of the Mean | 0.26 | 90 | -3.94 | -3.00 | No | Superiority or Other |
| Day 3 | Mixed Models Analysis | LS Mean Difference | -4.76 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | -5.29 | -4.23 | No | Superiority or Other |
| Day 7, pre-dose | Mixed Models Analysis | LS Mean Difference | -5.81 | Standard Error of the Mean | 0.45 | 2-Sided | 90 | -6.62 | -5.00 | No | Superiority or Other |
| Day 7, Hour 1 | Mixed Models Analysis | LS Mean Difference | -5.84 | Standard Error of the Mean | 0.49 | 2-Sided | 90 | -6.72 | -4.95 | No | Superiority or Other |
| Day 7, Hour 2 | Mixed Models Analysis | LS Mean Difference | -6.18 | Standard Error of the Mean | 0.55 | 2-Sided | 90 | -7.17 | -5.19 | No | Superiority or Other |
| Day 7, Hour 4 | Mixed Models Analysis | LS Mean Difference | -6.51 | Standard Error of the Mean | 0.53 | 2-Sided | 90 | -7.46 | -5.55 | No | Superiority or Other |
| Day 7, Hour 8 | Mixed Models Analysis | LS Mean Difference | -6.29 | Standard Error of the Mean | 0.43 | 2-Sided | 90 | -7.07 | -5.51 | No | Superiority or Other |
| Day 7, Hour 12 | Mixed Models Analysis | LS Mean Difference | -6.24 | Standard Error of the Mean | 0.44 | 2-Sided | 90 | -7.03 | -5.44 | No | Superiority or Other |
| Day 7, Hour 24 | Mixed Models Analysis | LS Mean Difference | -5.75 | Standard Error of the Mean | 0.42 | 2-Sided | 90 | -6.50 | -4.99 | No | Superiority or Other |
| Day 11 | Mixed Models Analysis | LS Mean Difference | -5.62 | Standard Error of the Mean | 0.53 | 2-Sided | 90 | -6.59 | -4.65 | No | Superiority or Other |
| Day 14, pre-dose | Mixed Models Analysis | LS Mean Difference | -5.76 | Standard Error of the Mean | 0.36 | 2-Sided | 90 | -6.42 | -5.10 | No | Superiority or Other |
| Day 14, Hour 1 | Mixed Models Analysis | LS Mean Difference | -5.96 | Standard Error of the Mean | 0.39 | 2-Sided | 90 | -6.67 | -5.24 | No | Superiority or Other |
| Day 14, Hour 2 | Mixed Models Analysis | LS Mean Difference | -6.14 | Standard Error of the Mean | 0.41 | 2-Sided | 90 | -6.90 | -5.38 | No | Superiority or Other |
| Day 14, Hour 4 | Mixed Models Analysis | LS Mean Difference | -6.42 | Standard Error of the Mean | 0.33 | 2-Sided | 90 | -7.03 | -5.81 | No | Superiority or Other |
| Day 14, Hour 8 | Mixed Models Analysis | LS Mean Difference | -6.64 | Standard Error of the Mean | 0.42 | 2-Sided | 90 | -7.41 | -5.87 | No | Superiority or Other |
| Day 14, Hour 12 | Mixed Models Analysis | LS Mean Difference | -6.40 | Standard Error of the Mean | 0.42 | 2-Sided | 90 | -7.18 | -5.63 | No | Superiority or Other |
| Day 14, Hour 24 | Mixed Models Analysis | LS Mean Difference | -5.77 | Standard Error of the Mean | 0.38 | 2-Sided | 90 | -6.47 | -5.07 | No | Superiority or Other |
| Follow-up, Day 25-29 | Mixed Models Analysis | LS Mean Difference | -2.66 | Standard Error of the Mean | 1.26 | 2-Sided | 90 | -4.96 | -0.35 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Day 7 (<4.0) |
|
| Day 14 (<6.0) |
|
| Day 14 (<5.0) |
|
| Day 14 (<4.0) |
|
| Day 1, Hour 1 (n=7,3,11) |
|
| Day 1, Hour 2 (n=7,3,11) |
|
| Day 1, Hour 4 (n=7,3,11) |
|
| Day 1, Hour 8 (n=7,3,11) |
|
| Day 1, Hour 12 (n=7,3,11) |
|
| Day 1, Hour 24 (n=7,3,11) |
|
| Day 7, Hour 0 (n=7,2,0) |
|
| Day 7, Hour 1 (n=7,2,0) |
|
| Day 7, Hour 2 (n=7,2,0) |
|
| Day 7, Hour 4 (n=7,2,0) |
|
| Day 7, Hour 8 (n=7,2,0) |
|
| Day 7, Hour 12 (n=7,2,0) |
|
| Day 7, Hour 24 (n=7,2,0) |
|
| Day 14, Hour 0 (n=6,2,0) |
|
| Day 14, Hour 1 (n=6,2,0) |
|
| Day 14, Hour 2 (n=6,2,0) |
|
| Day 14, Hour 4 (n=6,2,0) |
|
| Day 14, Hour 8 (n=6,2,0) |
|
| Day 14, Hour 12 (n=6,2,0) |
|
| Day 14, Hour 24 (n=6,2,0) |
|
| Day 1, Hour 1 (n=7,3,11) |
|
| Day 1, Hour 2 (n=7,3,11) |
|
| Day 1, Hour 4 (n=7,3,11) |
|
| Day 1, Hour 8 (n=7,3,11) |
|
| Day 1, Hour 12 (n=7,3,11) |
|
| Day 1, Hour 24 (n=7,3,11) |
|
| Day 7, Hour 0 (n=7,2,0) |
|
| Day 7, Hour 1 (n=7,2,0) |
|
| Day 7, Hour 2 (n=7,2,0) |
|
| Day 7, Hour 4 (n=7,2,0) |
|
| Day 7, Hour 8 (n=7,2,0) |
|
| Day 7, Hour 12 (n=7,2,0) |
|
| Day 7, Hour 24 (n=7,2,0) |
|
| Day 14, Hour 0 (n=6,2,0) |
|
| Day 14, Hour 1 (n=6,2,0) |
|
| Day 14, Hour 2 (n=6,2,0) |
|
| Day 14, Hour 4 (n=6,2,0) |
|
| Day 14, Hour 8 (n=6,2,0) |
|
| Day 14, Hour 12 (n=6,2,0) |
|
| Day 14, Hour 24 (n=6,2,0) |
|
| Day 1, Hour 1 (n=7,3,11,9) |
|
| Day 1, Hour 2 (n=7,3,11,9) |
|
| Day 1, Hour 4 (n=7,3,11,9) |
|
| Day 1, Hour 8 (n=7,3,11,9) |
|
| Day 1, Hour 12 (n=7,3,11,9) |
|
| Day 1, Hour 24 (n=7,3,11,9) |
|
| Day 7, pre-dose (n=7,2,0,6) |
|
| Day 7, Hour 1 (n=7,2,0,6) |
|
| Day 7, Hour 2 (n=7,2,0,6) |
|
| Day 7, Hour 4 (n=7,2,0,6) |
|
| Day 7, Hour 8 (n=7,2,0,6) |
|
| Day 7, Hour 12 (n=7,2,0,6) |
|
| Day 7, Hour 24 (n=7,2,0,6) |
|
| Day 14, pre-dose (n=6,2,0,6) |
|
| Day 14, Hour 1 (n=6,2,0,6) |
|
| Day 14, Hour 2 (n=6,2,0,6) |
|
| Day 14, Hour 4 (n=6,2,0,6) |
|
| Day 14, Hour 8 (n=6,2,0,6) |
|
| Day 14, Hour 12 (n=6,2,0,6) |
|
| Day 14, Hour 24 (n=6,2,0,6) |
|
| Follow-up (Day 25-29) (n=6,3,10,9) |
|
| Mixed Models Analysis |
| LS Mean Difference |
| -0.0152 |
| Standard Error of the Mean |
| 0.0631 |
| 2-Sided |
| 90 |
| -0.1269 |
| 0.0966 |
| No |
| Superiority or Other |
| Day 1, Hour 4 | Mixed Models Analysis | LS Mean Difference | -0.0331 | Standard Error of the Mean | 0.0422 | 2-Sided | 90 | -0.1078 | 0.0417 | No | Superiority or Other |
| Day 1, Hour 8 | Mixed Models Analysis | LS Mean Difference | 0.0035 | Standard Error of the Mean | 0.0443 | 2-Sided | 90 | -0.0750 | 0.0820 | No | Superiority or Other |
| Day 1, Hour 12 | Mixed Models Analysis | LS Mean Difference | -0.0502 | Standard Error of the Mean | 0.0367 | 2-Sided | 90 | -0.1153 | 0.0149 | No | Superiority or Other |
| Day 1, Hour 24 | Mixed Models Analysis | LS Mean Difference | -0.0080 | Standard Error of the Mean | 0.0553 | 2-Sided | 90 | -0.1058 | 0.0899 | No | Superiority or Other |
| Day 7, pre-dose | Mixed Models Analysis | LS Mean Difference | -0.0539 | Standard Error of the Mean | 0.0561 | 2-Sided | 90 | -0.1538 | 0.0460 | No | Superiority or Other |
| Day 7, Hour 1 | Mixed Models Analysis | LS Mean Difference | 0.0109 | Standard Error of the Mean | 0.0506 | 2-Sided | 90 | -0.0793 | 0.1010 | No | Superiority or Other |
| Day 7, Hour 2 | Mixed Models Analysis | LS Mean Difference | 0.0330 | Standard Error of the Mean | 0.0496 | 2-Sided | 90 | -0.0554 | 0.1213 | No | Superiority or Other |
| Day 7, Hour 4 | Mixed Models Analysis | LS Mean Difference | 0.0086 | Standard Error of the Mean | 0.0459 | 2-Sided | 90 | -0.0733 | 0.0905 | No | Superiority or Other |
| Day 7, Hour 8 | Mixed Models Analysis | LS Mean Difference | -0.0244 | Standard Error of the Mean | 0.0349 | 2-Sided | 90 | -0.0865 | 0.0378 | No | Superiority or Other |
| Day 7, Hour 12 | Mixed Models Analysis | LS Mean Difference | -0.0526 | Standard Error of the Mean | 0.0251 | 2-Sided | 90 | -0.0973 | -0.0079 | No | Superiority or Other |
| Day 7, Hour 24 | Mixed Models Analysis | LS Mean Difference | -0.0298 | Standard Error of the Mean | 0.0331 | 2-Sided | 90 | -0.0889 | 0.0292 | No | Superiority or Other |
| Day 14, pre-dose | Mixed Models Analysis | LS Mean Difference | -0.0167 | Standard Error of the Mean | 0.0268 | 2-Sided | 90 | -0.0649 | 0.0315 | No | Superiority or Other |
| Day 14, Hour 1 | Mixed Models Analysis | LS Mean Difference | 0.0616 | Standard Error of the Mean | 0.0337 | 2-Sided | 90 | 0.0010 | 0.1222 | No | Superiority or Other |
| Day 14, Hour 2 | Mixed Models Analysis | LS Mean Difference | 0.1025 | Standard Error of the Mean | 0.0512 | 2-Sided | 90 | 0.0104 | 0.1945 | No | Superiority or Other |
| Day 14, Hour 4 | Mixed Models Analysis | LS Mean Difference | 0.0062 | Standard Error of the Mean | 0.0495 | 2-Sided | 90 | -0.0827 | 0.0952 | No | Superiority or Other |
| Day 14, Hour 8 | Mixed Models Analysis | LS Mean Difference | 0.0124 | Standard Error of the Mean | 0.0443 | 2-Sided | 90 | -0.0672 | 0.0919 | No | Superiority or Other |
| Day 14, Hour 12 | Mixed Models Analysis | LS Mean Difference | -0.0186 | Standard Error of the Mean | 0.0408 | 2-Sided | 90 | -0.0918 | 0.0547 | No | Superiority or Other |
| Day 14, Hour 24 | Mixed Models Analysis | LS Mean Difference | -0.0413 | Standard Error of the Mean | 0.0433 | 2-Sided | 90 | -0.1192 | 0.0365 | No | Superiority or Other |
| Follow-up, Day 25-29 | Mixed Models Analysis | LS Mean Difference | 0.4011 | Standard Error of the Mean | 0.3916 | 2-Sided | 90 | -0.2968 | 1.0990 | No | Superiority or Other |
| Day 1, Hour 1 | Mixed Models Analysis | LS Mean Difference | 0.1175 | Standard Error of the Mean | 0.0537 | 2-Sided | 90 | 0.0223 | 0.2127 | No | Superiority or Other |
| Day 1, Hour 2 | Mixed Models Analysis | LS Mean Difference | 0.3845 | Standard Error of the Mean | 0.0802 | 2-Sided | 90 | 0.2424 | 0.5266 | No | Superiority or Other |
| Day 1, Hour 4 | Mixed Models Analysis | LS Mean Difference | 0.3812 | Standard Error of the Mean | 0.0536 | 2-Sided | 90 | 0.2862 | 0.4762 | No | Superiority or Other |
| Day 1, Hour 8 | Mixed Models Analysis | LS Mean Difference | 0.2841 | Standard Error of the Mean | 0.0563 | 2-Sided | 90 | 0.1843 | 0.3838 | No | Superiority or Other |
| Day 1, Hour 12 | Mixed Models Analysis | LS Mean Difference | 0.1462 | Standard Error of the Mean | 0.0467 | 2-Sided | 90 | 0.0635 | 0.2289 | No | Superiority or Other |
| Day 1, Hour 24 | Mixed Models Analysis | LS Mean Difference | 0.1680 | Standard Error of the Mean | 0.0702 | 2-Sided | 90 | 0.0436 | 0.2924 | No | Superiority or Other |
| Day 7, pre-dose | Mixed Models Analysis | LS Mean Difference | 0.1303 | Standard Error of the Mean | 0.0830 | 2-Sided | 90 | -0.0172 | 0.2778 | No | Superiority or Other |
| Day 7, Hour 1 | Mixed Models Analysis | LS Mean Difference | 0.1953 | Standard Error of the Mean | 0.0747 | 90 | 0.0625 | 0.3281 | No | Superiority or Other |
| Day 7, Hour 2 | Mixed Models Analysis | LS Mean Difference | 0.5409 | Standard Error of the Mean | 0.0729 | 2-Sided | 90 | 0.4110 | 0.6707 | No | Superiority or Other |
| Day 7, Hour 4 | Mixed Models Analysis | LS Mean Difference | 0.5235 | Standard Error of the Mean | 0.0675 | 2-Sided | 90 | 0.4032 | 0.6438 | No | Superiority or Other |
| Day 7, Hour 8 | Mixed Models Analysis | LS Mean Difference | 0.3857 | Standard Error of the Mean | 0.0512 | 2-Sided | 90 | 0.2944 | 0.4769 | No | Superiority or Other |
| Day 7, Hour 12 | Mixed Models Analysis | LS Mean Difference | 0.0216 | Standard Error of the Mean | 0.0368 | 2-Sided | 90 | -0.0439 | 0.0872 | No | Superiority or Other |
| Day 7, Hour 24 | Mixed Models Analysis | LS Mean Difference | 0.1708 | Standard Error of the Mean | 0.0486 | 2-Sided | 90 | 0.0841 | 0.2574 | No | Superiority or Other |
| Day 14, pre-dose | Mixed Models Analysis | LS Mean Difference | 0.1660 | Standard Error of the Mean | 0.0377 | 2-Sided | 90 | 0.0982 | 0.2338 | No | Superiority or Other |
| Day 14, Hour 1 | Mixed Models Analysis | LS Mean Difference | 0.3524 | Standard Error of the Mean | 0.0477 | 2-Sided | 90 | 0.2667 | 0.4380 | No | Superiority or Other |
| Day 14, Hour 2 | Mixed Models Analysis | LS Mean Difference | 0.5631 | Standard Error of the Mean | 0.0724 | 2-Sided | 90 | 0.4330 | 0.6932 | No | Superiority or Other |
| Day 14, Hour 4 | Mixed Models Analysis | LS Mean Difference | 0.5807 | Standard Error of the Mean | 0.0700 | 2-Sided | 90 | 0.4549 | 0.7065 | No | Superiority or Other |
| Day 14, Hour 8 | Mixed Models Analysis | LS Mean Difference | 0.2814 | Standard Error of the Mean | 0.0627 | 2-Sided | 90 | 0.1688 | 0.3940 | No | Superiority or Other |
| Day 14, Hour 12 | Mixed Models Analysis | LS Mean Difference | 0.1982 | Standard Error of the Mean | 0.0577 | 2-Sided | 90 | 0.0945 | 0.3019 | No | Superiority or Other |
| Day 14, Hour 24 | Mixed Models Analysis | LS Mean Difference | 0.1465 | Standard Error of the Mean | 0.0615 | 2-Sided | 90 | 0.0361 | 0.2569 | No | Superiority or Other |
| Follow-up, Day 25-29 | Mixed Models Analysis | LS Mean Difference | 0.8565 | Standard Error of the Mean | 0.4796 | 2-Sided | 90 | 0.0017 | 1.7112 | No | Superiority or Other |
| Day 1, Hour 1 (n=7,3,11,9) |
|
| Day 1, Hour 2 (n=7,3,11,9) |
|
| Day 1, Hour 4 (n=7,3,11,9) |
|
| Day 1, Hour 8 (n=7,3,11,9) |
|
| Day 1, Hour 12 (n=7,3,11,9) |
|
| Day 1, Hour 24 (n=7,3,11,9) |
|
| Day 7, pre-dose (n=7,2,0,6) |
|
| Day 7, Hour 1 (n=7,2,0,6) |
|
| Day 7, Hour 2 (n=7,2,0,6) |
|
| Day 7, Hour 4 (n=7,2,0,6) |
|
| Day 7, Hour 8 (n=7,2,0,6) |
|
| Day 7, Hour 12 (n=7,2,0,6) |
|
| Day 7, Hour 24 (n=7,2,0,6) |
|
| Day 14, pre-dose (n=6,2,0,6) |
|
| Day 14, Hour 1 (n=6,2,0,6) |
|
| Day 14, Hour 2 (n=6,2,0,6) |
|
| Day 14, Hour 4 (n=6,2,0,6) |
|
| Day 14, Hour 8 (n=6,2,0,6) |
|
| Day 14, Hour 12 (n=6,2,0,6) |
|
| Day 14, Hour 24 (n=6,2,0,6) |
|
| Follow-up Day 25-29 (n=6,3,10,9) |
|
| LS Mean Difference |
| -0.179 |
| Standard Error of the Mean |
| 0.205 |
| 2-Sided |
| 90 |
| -0.533 |
| 0.175 |
| No |
| Superiority or Other |
| Day 1, Hour 4 | Mixed Models Analysis | LS Mean Difference | -0.258 | Standard Error of the Mean | 0.180 | 2-Sided | 90 | -0.568 | 0.052 | No | Superiority or Other |
| Day 1, Hour 8 | Mixed Models Analysis | LS Mean Difference | -0.046 | Standard Error of the Mean | 0.201 | 90 | -0.390 | 0.298 | No | Superiority or Other |
| Day 1, Hour 12 | Mixed Models Analysis | LS Mean Difference | -0.284 | Standard Error of the Mean | 0.168 | 90 | -0.575 | 0.006 | No | Superiority or Other |
| Day 1, Hour 24 | Mixed Models Analysis | LS Mean Difference | -0.166 | Standard Error of the Mean | 0.235 | 2-Sided | 90 | -0.569 | 0.237 | No | Superiority or Other |
| Day 7, pre-dose | Mixed Models Analysis | LS Mean Difference | -0.263 | Standard Error of the Mean | 0.230 | 2-Sided | 90 | -0.657 | 0.132 | No | Superiority or Other |
| Day 7, Hour 1 | Mixed Models Analysis | LS Mean Difference | -0.080 | Standard Error of the Mean | 0.221 | 2-Sided | 90 | -0.460 | 0.299 | No | Superiority or Other |
| Day 7, Hour 2 | Mixed Models Analysis | LS Mean Difference | -0.082 | Standard Error of the Mean | 0.180 | 2-Sided | 90 | -0.392 | 0.228 | No | Superiority or Other |
| Day 7, Hour 4 | Mixed Models Analysis | LS Mean Difference | -0.083 | Standard Error of the Mean | 0.189 | 2-Sided | 90 | -0.408 | 0.242 | No | Superiority or Other |
| Day 7, Hour 8 | Mixed Models Analysis | LS Mean Difference | -0.207 | Standard Error of the Mean | 0.174 | 2-Sided | 90 | -0.508 | 0.095 | No | Superiority or Other |
| Day 7, Hour 12 | Mixed Models Analysis | LS Mean Difference | -0.130 | Standard Error of the Mean | 0.186 | 2-Sided | 90 | -0.451 | 0.191 | No | Superiority or Other |
| Day 7, Hour 24 | Mixed Models Analysis | LS Mean Difference | -0.125 | Standard Error of the Mean | 0.186 | 2-Sided | 90 | -0.445 | 0.196 | No | Superiority or Other |
| Day 14, pre-dose | Mixed Models Analysis | LS Mean Difference | -0.188 | Standard Error of the Mean | 0.162 | 2-Sided | 90 | -0.472 | 0.097 | No | Superiority or Other |
| Day 14, Hour 1 | Mixed Models Analysis | LS Mean Difference | -0.152 | Standard Error of the Mean | 0.161 | 2-Sided | 90 | -0.434 | 0.130 | No | Superiority or Other |
| Day 14, Hour 2 | Mixed Models Analysis | LS Mean Difference | -0.231 | Standard Error of the Mean | 0.155 | 2-Sided | 90 | -0.504 | 0.043 | No | Superiority or Other |
| Day 14, Hour 4 | Mixed Models Analysis | LS Mean Difference | -0.405 | Standard Error of the Mean | 0.184 | 2-Sided | 90 | -0.722 | -0.088 | No | Superiority or Other |
| Day 14, Hour 8 | Mixed Models Analysis | LS Mean Difference | -0.249 | Standard Error of the Mean | 0.180 | 2-Sided | 90 | -0.560 | 0.062 | No | Superiority or Other |
| Day 14, Hour 12 | Mixed Models Analysis | LS Mean Difference | -0.163 | Standard Error of the Mean | 0.176 | 2-Sided | 90 | -0.467 | 0.141 | No | Superiority or Other |
| Day 14, Hour 24 | Mixed Models Analysis | LS Mean Difference | -0.317 | Standard Error of the Mean | 0.183 | 2-Sided | 90 | -0.633 | -0.002 | No | Superiority or Other |
| Follow-up, Day 25-29 | Mixed Models Analysis | LS Mean Difference | -0.094 | Standard Error of the Mean | 0.339 | 2-Sided | 90 | -0.683 | 0.496 | No | Superiority or Other |
| Day 1, Hour 1 | Mixed Models Analysis | LS Mean Difference | 0.050 | Standard Error of the Mean | 0.266 | 2-Sided | 90 | -0.406 | 0.505 | No | Superiority or Other |
| Day 1, Hour 2 | Mixed Models Analysis | LS Mean Difference | 0.257 | Standard Error of the Mean | 0.260 | 2-Sided | 90 | -0.193 | 0.707 | No | Superiority or Other |
| Day 1, Hour 4 | Mixed Models Analysis | LS Mean Difference | 0.091 | Standard Error of the Mean | 0.229 | 2-Sided | 90 | -0.302 | 0.485 | No | Superiority or Other |
| Day 1, Hour 8 | Mixed Models Analysis | LS Mean Difference | 0.330 | Standard Error of the Mean | 0.256 | 2-Sided | 90 | -0.107 | 0.768 | No | Superiority or Other |
| Day 1, Hour 12 | Mixed Models Analysis | LS Mean Difference | 0.283 | Standard Error of the Mean | 0.214 | 2-Sided | 90 | -0.087 | 0.653 | No | Superiority or Other |
| Day 1, Hour 24 | Mixed Models Analysis | LS Mean Difference | 0.488 | Standard Error of the Mean | 0.299 | 2-Sided | 90 | -0.024 | 1.000 | No | Superiority or Other |
| Day 7, pre-dose | Mixed Models Analysis | LS Mean Difference | 0.206 | Standard Error of the Mean | 0.327 | 2-Sided | 90 | -0.356 | 0.768 | No | Superiority or Other |
| Day 7, Hour 1 | Mixed Models Analysis | LS Mean Difference | 0.123 | Standard Error of the Mean | 0.310 | 2-Sided | 90 | -0.410 | 0.656 | No | Superiority or Other |
| Day 7, Hour 2 | Mixed Models Analysis | LS Mean Difference | 0.396 | Standard Error of the Mean | 0.246 | 2-Sided | 90 | -0.025 | 0.818 | No | Superiority or Other |
| Day 7, Hour 4 | Mixed Models Analysis | LS Mean Difference | -0.077 | Standard Error of the Mean | 0.260 | 2-Sided | 90 | -0.523 | 0.368 | No | Superiority or Other |
| Day 7, Hour 8 | Mixed Models Analysis | LS Mean Difference | 0.254 | Standard Error of the Mean | 0.237 | 2-Sided | 90 | -0.154 | 0.661 | No | Superiority or Other |
| Day 7, Hour 12 | Mixed Models Analysis | LS Mean Difference | -0.125 | Standard Error of the Mean | 0.256 | 2-Sided | 90 | -0.564 | 0.315 | No | Superiority or Other |
| Day 7, Hour 24 | Mixed Models Analysis | LS Mean Difference | 0.458 | Standard Error of the Mean | 0.256 | 2-Sided | 90 | 0.019 | 0.897 | No | Superiority or Other |
| Day 14, pre-dose | Mixed Models Analysis | LS Mean Difference | 0.418 | Standard Error of the Mean | 0.215 | 2-Sided | 90 | 0.043 | 0.792 | No | Superiority or Other |
| Day 14, Hour 1 | Mixed Models Analysis | LS Mean Difference | 0.521 | Standard Error of the Mean | 0.213 | 2-Sided | 90 | 0.150 | 0.893 | No | Superiority or Other |
| Day 14, Hour 2 | Mixed Models Analysis | LS Mean Difference | 0.530 | Standard Error of the Mean | 0.204 | 2-Sided | 90 | 0.172 | 0.888 | No | Superiority or Other |
| Day 14, Hour 4 | Mixed Models Analysis | LS Mean Difference | 0.357 | Standard Error of the Mean | 0.247 | 2-Sided | 90 | -0.069 | 0.782 | No | Superiority or Other |
| Day 14, Hour 8 | Mixed Models Analysis | LS Mean Difference | 0.088 | Standard Error of the Mean | 0.242 | 2-Sided | 90 | -0.328 | 0.503 | No | Superiority or Other |
| Day 14, Hour 12 | Mixed Models Analysis | LS Mean Difference | 0.406 | Standard Error of the Mean | 0.236 | 2-Sided | 90 | 0.000 | 0.812 | No | Superiority or Other |
| Day 14, Hour 24 | Mixed Models Analysis | LS Mean Difference | 0.377 | Standard Error of the Mean | 0.247 | 2-Sided | 90 | -0.047 | 0.802 | No | Superiority or Other |
| Follow-up, Day 25-29 | Mixed Models Analysis | LS Mean Difference | -0.223 | Standard Error of the Mean | 0.418 | 2-Sided | 90 | -0.949 | 0.502 | No | Superiority or Other |
| Change at Day 1 (n=7,3,11,9) |
|
| Change at Day 7 (n=7,2,0,6) |
|
| Change at Day 14 (n=6,2,0,6) |
|
| LS Mean Difference |
| 61.97 |
| Standard Error of the Mean |
| 88.27 |
| 2-Sided |
| 90 |
| -94.87 |
| 218.82 |
| No |
| Superiority or Other |
| Day 14 | Mixed Models Analysis | LS Mean Difference | 107.96 | Standard Error of the Mean | 100.38 | 2-Sided | 90 | -71.20 | 287.11 | No | Superiority or Other |
| Day 1 | Mixed Models Analysis | LS Mean Difference | 433.21 | Standard Error of the Mean | 211.71 | 2-Sided | 90 | 58.30 | 808.13 | No | Superiority or Other |
| Day 7 | Mixed Models Analysis | LS Mean Difference | 13.20 | Standard Error of the Mean | 125.47 | 2-Sided | 90 | -208.07 | 234.47 | No | Superiority or Other |
| Day 14 | Mixed Models Analysis | LS Mean Difference | -29.83 | Standard Error of the Mean | 142.95 | 2-Sided | 90 | -285.26 | 225.60 | No | Superiority or Other |
| Change at Day 1 (n=7,3,11,9) |
|
| Change at Day 7 (n=7,2,0,6) |
|
| Change at Day 14 (n=6,2,0,6) |
|
| LS Mean Difference |
| 3.67 |
| Standard Error of the Mean |
| 0.94 |
| 2-Sided |
| 90 |
| 1.97 |
| 5.37 |
| No |
| Superiority or Other |
| Day 14 | Mixed Models Analysis | LS Mean Difference | 8.10 | Standard Error of the Mean | 1.03 | 2-Sided | 90 | 6.24 | 9.96 | No | Superiority or Other |
| Day 1 | Mixed Models Analysis | LS Mean Difference | 13.12 | Standard Error of the Mean | 2.00 | 2-Sided | 90 | 9.65 | 16.59 | No | Superiority or Other |
| Day 7 | Mixed Models Analysis | LS Mean Difference | 27.99 | Standard Error of the Mean | 1.40 | 2-Sided | 90 | 25.49 | 30.49 | No | Superiority or Other |
| Day 14 | Mixed Models Analysis | LS Mean Difference | 28.77 | Standard Error of the Mean | 1.48 | 2-Sided | 90 | 26.14 | 31.41 | No | Superiority or Other |
| Change at Day 1 (n=7,3,11,9) |
|
| Change at Day 7 (n=7,2,0,6) |
|
| Change at Day 14 (n=6,2,0,6) |
|
| LS Mean Difference |
| 2.91 |
| Standard Error of the Mean |
| 1.29 |
| 2-Sided |
| 90 |
| 0.71 |
| 5.11 |
| No |
| Superiority or Other |
| Day 14 | Mixed Models Analysis | LS Mean Difference | 3.59 | Standard Error of the Mean | 1.33 | 2-Sided | 90 | 1.33 | 5.85 | No | Superiority or Other |
| Day 1 | Mixed Models Analysis | LS Mean Difference | 1.51 | Standard Error of the Mean | 1.64 | 2-Sided | 90 | -1.29 | 4.31 | No | Superiority or Other |
| Day 7 | Mixed Models Analysis | LS Mean Difference | 7.73 | Standard Error of the Mean | 1.86 | 2-Sided | 90 | 4.57 | 10.89 | No | Superiority or Other |
| Day 14 | Mixed Models Analysis | LS Mean Difference | 9.07 | Standard Error of the Mean | 1.86 | 2-Sided | 90 | 5.91 | 12.23 | No | Superiority or Other |