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This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled, twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM inadequately controlled on diet and exercise alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PF-06882961 40 mg | Experimental | Participants will be titrated up to 2 weeks to reach desired dose level |
|
| PF-06882961 80 mg | Experimental | Participants will be titrated up to 4 weeks to reach desired dose level |
|
| PF-06882961 120 mg | Experimental | Participants will be titrated up to 6 weeks to reach desired dose level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 3 matching placebo tablets taken twice a day (BID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. | Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) |
| Number of Participants With Clinical Laboratory Abnormalities | Leukocytes (10^9/liter [L]) bilirubin (micromol/L), glucose (millimoles [mmol]/L), triacylglycerol lipase (microkatals [microkat]/L): greater than (>) 1.5*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits [mU]/L): less than (<) 0.8*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): >1.2*ULN; triglycerides: >1.3*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): >3.0*ULN; cholesterol (mmol/L): >1.3*ULN; urine glucose, ketones urine protein, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase: greater than or equal to (>=) 1; granular casts, hyaline casts: >1. | Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) |
| Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline | Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP <90 mmHg, maximum of SBP >=30 mmHg decrease from baseline and maximum of SBP >=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP <50 mmHg, maximum of DBP >20 mmHg decrease from baseline and maximum of DBP >=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate <40 BPM and maximum of absolute supine pulse rate >120 BPM. Baseline was defined as the time-matched value from the average of the triplicate recordings on Day -1. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961 | AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24). | Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1 and 56 |
| Maximum Plasma Concentration (Cmax) Observed of PF-06882961 |
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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 |
|---|---|---|---|---|---|---|
| P-one clinic, Keikokai medical corporation | Hachiōji | Tokyo | 192-0071 | Japan |
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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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65 participants signed the inform consent form (ICF). 28 participants were screen failures who did not meet criteria and were not enrolled. 37 participants enrolled into the study and assigned to a study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants with type 2 diabetes mellitus (T2DM) were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks. |
| FG001 | PF-06882961 40 mg | Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks. |
| FG002 | PF-06882961 80 mg | Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks. |
| FG003 | PF-06882961 120 mg | Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks. |
| BG001 | PF-06882961 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 | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) |
|
Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)
Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
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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 T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v.23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2020 | Dec 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2021 | Dec 14, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000731016 | danuglipron |
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| PF-06882961 |
| Drug |
Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks. |
|
| Baseline (1 Day before dosing) up to last dose (maximum up to Week 8) |
| Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline | PR interval had following categories: maximum absolute PR interval >=300 milliseconds (msec); when baseline PR interval >200 msec and maximum increase from baseline in PR interval >=25 percent; when baseline PR interval less than or equal to (<=) 200 msec and maximum increase from baseline in PR interval >=50 percent. QRS interval had following categories: maximum absolute QRS interval >=140 msec; maximum increase from baseline in QRS interval >=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval >450 msec to <=480 msec; absolute QTCF interval >480 msec to <=500 msec; absolute QTCF interval >500 msec; QTCF interval increase from baseline >=30 msec to <=60 msec; QTCF interval increase from baseline >60 msec. | Baseline (1 Day before dosing) up to last dose (maximum up to Week 8) |
| Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961 | Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56 |
| Terminal Phase Half-Life (t1/2) of PF-06882961 | t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56 |
Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.
| BG002 | PF-06882961 80 mg | Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks. |
| BG003 | PF-06882961 120 mg | Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Placebo | Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks. |
| OG001 | PF-06882961 40 mg | Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks. |
| OG002 | PF-06882961 80 mg | Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks. |
| OG003 | PF-06882961 120 mg | Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks. |
|
|
| Primary | Number of Participants With Clinical Laboratory Abnormalities | Leukocytes (10^9/liter [L]) bilirubin (micromol/L), glucose (millimoles [mmol]/L), triacylglycerol lipase (microkatals [microkat]/L): greater than (>) 1.5*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits [mU]/L): less than (<) 0.8*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): >1.2*ULN; triglycerides: >1.3*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): >3.0*ULN; cholesterol (mmol/L): >1.3*ULN; urine glucose, ketones urine protein, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase: greater than or equal to (>=) 1; granular casts, hyaline casts: >1. | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) |
|
|
|
| Primary | Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline | Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP <90 mmHg, maximum of SBP >=30 mmHg decrease from baseline and maximum of SBP >=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP <50 mmHg, maximum of DBP >20 mmHg decrease from baseline and maximum of DBP >=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate <40 BPM and maximum of absolute supine pulse rate >120 BPM. Baseline was defined as the time-matched value from the average of the triplicate recordings on Day -1. | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline (1 Day before dosing) up to last dose (maximum up to Week 8) |
|
|
|
| Primary | Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline | PR interval had following categories: maximum absolute PR interval >=300 milliseconds (msec); when baseline PR interval >200 msec and maximum increase from baseline in PR interval >=25 percent; when baseline PR interval less than or equal to (<=) 200 msec and maximum increase from baseline in PR interval >=50 percent. QRS interval had following categories: maximum absolute QRS interval >=140 msec; maximum increase from baseline in QRS interval >=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval >450 msec to <=480 msec; absolute QTCF interval >480 msec to <=500 msec; absolute QTCF interval >500 msec; QTCF interval increase from baseline >=30 msec to <=60 msec; QTCF interval increase from baseline >60 msec. | Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline (1 Day before dosing) up to last dose (maximum up to Week 8) |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961 | AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24). | Pharmacokinetic (PK) parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports AUC24 of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". Here "Number Analyzed" signifies participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1 and 56 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) Observed of PF-06882961 | PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports Cmax of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". Here "Number Analyzed" signifies participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56 |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961 | PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports Tmax of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". Here "Number Analyzed" signifies participants evaluable at specified time points. | Posted | Median | Full Range | Hours | Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56 |
|
|
|
| Secondary | Terminal Phase Half-Life (t1/2) of PF-06882961 | t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports t1/2 of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". | Posted | Mean | Standard Deviation | Hours | Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56 |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | PF-06882961 40 mg | Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks. | 0 | 10 | 0 | 10 | 7 | 10 |
| EG002 | PF-06882961 80 mg | Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks. | 0 | 9 | 0 | 9 | 9 | 9 |
| EG003 | PF-06882961 120 mg | Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks. | 0 | 9 | 0 | 9 | 9 | 9 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v.23.1 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA v.23.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v.23.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v.23.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v.23.1 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA v.23.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA v.23.1 | Non-systematic Assessment |
|
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA v.23.1 | 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 the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D004700 | Endocrine System Diseases |
| Maximum of SBP >=30 mmHg decrease |
|
| Maximum of SBP >=30 mmHg increase |
|
| Minimum of absolute DBP <50 mmHg |
|
| Maximum of DBP >=20 mmHg decrease |
|
| Maximum of DBP >=20 mmHg increase |
|
| Minimum of absolute pulse rate <40 BPM |
|
| Maximum of absolute pulse rate >120 BPM |
|
| Baseline PR >200 msec and maximum increase in PR >=25% |
|
| Baseline PR <=200 msec and maximum increase in PR >=50% |
|
| Maximum absolute QRS >=140 msec |
|
| Maximum increase in QRS >=50% |
|
| Absolute QTCF interval >450 msec to <=480 msec |
|
| Absolute QTCF interval >480 msec to <=500 msec |
|
| Absolute QTCF >500 msec |
|
| QTCF increase >=30 msec to <=60 msec |
|
| QTCF increase >60 msec |
|
| Day 56 |
|
|
| Day 56 |
|
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| Day 56 |
|
|