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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021358-20 | EudraCT Number |
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PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-00489791 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00489791 | Drug | Tablet, 20 mg once daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12 | UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 12], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 12]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR. | Baseline, Week 12 (Day 5, 6, 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16 | UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of specified Week], and with last sample collected on the morning of scheduled clinic visit [Day 7 of specified Week]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16 | Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months. Baseline HbA1c level was determined predose at Week 0 (Day 1). | Baseline, Week 12, 16 (follow-up) |
| Number of Participants With Vital Signs Abnormalities |
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 |
|---|---|---|---|---|---|---|
| Saadat Ansari Internal Medicine | Huntsville | Alabama | 35801 | United States | ||
| The Office of Iqbal Saeed MD, LLC |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to PF-00489791 tablet orally once daily for 12 weeks. |
| FG001 | PF-00489791 20 mg | PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Tablet, placebo once daily for 12 weeks |
|
| Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7) |
| Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16 | UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 3, 6, 12, 16], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 3, 6, 12, 16]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR. | Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7) |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16 | The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) = 175*(sCr/88.4)^-1.154*(Age)^-0.203*(0.742 if female)*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1). | Baseline, Week 3, 6, 12, 16 (follow-up) |
| Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16 | Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + ([systolic blood pressure - diastolic blood pressure]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart. | Week 0, 3, 6, 12, 16 (follow-up) |
| Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16 | Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1). | Baseline, Week 3, 6, 12, 16 (follow-up) |
| Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16 | TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1). | Baseline, Week 3, 6, 12, 16 (follow-up) |
| Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16 | The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1). | Baseline, Week 12, 16 (follow-up) |
| Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16 | Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1). | Baseline, Week 12, 16 (follow-up) |
| Plasma Concentration Versus Time Summary of PF-00489791 | Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6 |
Criteria for determining vital signs abnormalities: supine or standing systolic BP (SBP) (less than [<] 90 mmHg and increase or decrease of greater than or equal to [>=] 30 mmHg compared to baseline value), supine or standing diastolic BP (DBP) (<50 mmHg and increase or decrease of >=20 mmHg compared to baseline value), supine pulse rate (>120 beats per minute [bpm] or <40 bpm), standing pulse rate (>140 bpm or <40 bpm). For supine, baseline was the average of the triplicate predose readings at Week 0 (Day 1). For standing, baseline is the predose reading at Week 0 (Day 1). Only categories who had at least 1 participant are reported. |
| Baseline up to Week 16 (follow-up) |
| Number of Participants With Edema and Fluid Overload | Participants were assessed for signs of edema and fluid overload. | Week 0, 3, 6, 12, 16 (follow-up) |
| Number of Participants With Increased Use of Diuretics | Baseline up to Week 16 (follow-up) |
| Number of Participants With Laboratory Test Abnormalities | Criteria for laboratory test abnormalities: Hematology (hemoglobin [<0.8*lower limit of normal{LLN}], hematocrit [<0.8*LLN], red blood cells [<0.8*LLN], platelet [<0.5*LLN/>1.75*upper limit of normal{ULN}], white blood cells [<0.6*LLN/>1.5*ULN], lymphocytes [<0.8*LLN/>1.2*ULN], neutrophils [<0.8*LLN/>1.2*ULN], basophils [>1.2*ULN], eosinophils [>1.2*ULN], monocytes [>1.2*ULN]); Liver Function (total/direct/indirect bilirubin [>1.5*ULN], aspartate aminotransferase/ alanine aminotransferase/ gamma glutamyl transpeptidase/ lactate dehydrogenase/ alkaline phosphatase [>3.0*ULN]); Renal Function (blood urea nitrogen/ creatinine [>1.3*ULN], uric acid [>1.2*ULN]); Electrolytes (sodium [<0.95*LLN/>1.05*ULN], potassium, chloride, calcium, bicarbonate [<0.9*LLN/>1.1*ULN]); Clinical Chemistry (glucose [<0.6*LLN/>1.5*ULN], glycosylated hemoglobin [>1.3*ULN], Creatine Kinase [>2.0*ULN], Amylase, Lipase[>1.5*ULN]). | Baseline up to Week 16 (follow-up) |
| 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 medication without regard to possibility of causal relationship. SAE: 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 medication and up to Week 16 (follow-up) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs) | Baseline up to Week 16 (follow-up) |
| Huntsville |
| Alabama |
| 35805 |
| United States |
| AKDHC Medical Research Services, LLC* | Glendale | Arizona | 85306 | United States |
| Southwest Clinical Research Institute, LLC | Tempe | Arizona | 85281 | United States |
| Southwest Clinical Research Institute, LLC | Tempe | Arizona | 85284 | United States |
| North America Research Institute | Azusa | California | 91702 | United States |
| North American Research Institute / California Kidney Specialist | Azusa | California | 91702 | United States |
| Citrus Dialysis Center | Covina | California | 91723 | United States |
| California Institute of Renal Research | La Mesa | California | 91942 | United States |
| Capital Nephrology Clinical Research | Sacramento | California | 95825 | United States |
| California Kidney Specialists | San Dimas | California | 91773 | United States |
| American Institute of Research | Whittier | California | 90602 | United States |
| Whittier Internal Medicine Nephrology Medical Group | Whittier | California | 90602 | United States |
| North Valley Nephrology | Yuba City | California | 95991 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| Palm Springs Research Institute | Hialeah | Florida | 33012 | United States |
| ASA Clinical Research, LLC | Jupiter | Florida | 33458 | United States |
| Lakeview Medical Research | Summerfield | Florida | 34491 | United States |
| Rockdale Medical Research Associates | Conyers | Georgia | 30094 | United States |
| Renal Physicians of Georgia | Macon | Georgia | 31217 | United States |
| Boise Kidney and Hypertension Institute | Meridian | Idaho | 83642 | United States |
| Chicago Clinical Research Institute, Inc. | Chicago | Illinois | 60616 | United States |
| Associates in Nephrology, SC | Evergreen Park | Illinois | 60805 | United States |
| Research by Design, LLC | Evergreen Park | Illinois | 60805 | United States |
| RenalCare Associates | Peoria | Illinois | 61603 | United States |
| Investigative Clinical Research of Indiana, LLC | Elwood | Indiana | 46036 | United States |
| Kansas Nephrology Research Institute, LLC | Wichita | Kansas | 67214 | United States |
| Four Rivers Clinical Research, Inc. | Paducah | Kentucky | 42003 | United States |
| Crescent City Clinical Research Center | Metairie | Louisiana | 70006 | United States |
| Northwest Louisiana Nephrology | Shreveport | Louisiana | 71101 | United States |
| Biolab Research, LLC | Rockville | Maryland | 20852 | United States |
| Alzohaili Medical Consultants | Dearborn | Michigan | 48124 | United States |
| Apex Medical Research, AMR, Inc. | Flint | Michigan | 48504 | United States |
| Apex Medical Research, MI, Inc. | Flint | Michigan | 48504 | United States |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | United States |
| Lincoln Nephrology and Hypertension | Lincoln | Nebraska | 68510 | United States |
| Nebraska Nephrology Research Institute, LLC - Research Management, Inc. | Lincoln | Nebraska | 68510 | United States |
| Alliance Against Diabetes | Las Vegas | Nevada | 89101 | United States |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | United States |
| Jacobi Medical Center - Department of Medicine - Nephrology | The Bronx | New York | 10461 | United States |
| Mountain Kidney and Hypertension Associates, PA | Asheville | North Carolina | 28801 | United States |
| Trial Management Associates | Wilmington | North Carolina | 28401 | United States |
| Lake Medical Research | Willoughby Hills | Ohio | 44094 | United States |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | 18017 | United States |
| Preferred Primary Care Physicians, Inc. | Uniontown | Pennsylvania | 15401 | United States |
| Columbia Nephrology Associates, PA | Columbia | South Carolina | 29203 | United States |
| Carolina Nephrology, PA | Greenville | South Carolina | 29605 | United States |
| Palmetto Nephrology, PA | Orangeburg | South Carolina | 29118 | United States |
| South Carolina Nephrology & Hypertension Ctr, Inc | Orangeburg | South Carolina | 29118 | United States |
| South Carolina Nephrology and Hypertension Center | Orangeburg | South Carolina | 29118 | United States |
| Central Texas Kidney Associates | Austin | Texas | 78751 | United States |
| Research Management, Inc. | Austin | Texas | 78751 | United States |
| Diagnostic Clinic of Houston, PA | Houston | Texas | 77004 | United States |
| Houston Nephrology Research | Houston | Texas | 77024 | United States |
| Research Across America | Houston | Texas | 77054 | United States |
| Renal Associates, PA | San Antonio | Texas | 78215 | United States |
| San Antonio Kidney Disease Center Physicians Group, P.L.L.C. | San Antonio | Texas | 78229 | United States |
| Nephrology Associates of Northern Virginia, Inc. | Fairfax | Virginia | 22033 | United States |
| Nephrology Specialists, P.C. | Mechanicsville | Virginia | 23116 | United States |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
| Renal Remission & Hypertension Consultants, PLLC | Bremerton | Washington | 98310 | United States |
| Sound Medical Research | Port Orchard | Washington | 98366 | United States |
| Renal Remission and Hypertension Clinic | Silverdale | Washington | 98383 | United States |
| Renal Research Practice | Gosford | New South Wales | 2250 | Australia |
| John Hunter Hospital | Newcastle | New South Wales | 2305 | Australia |
| Department of Nephrology | New Lambton | Newcastle | 2305 | Australia |
| Pharmacy Department | New Lambton | Newcastle | 2305 | Australia |
| Melbourne Renal Research Group | Reservoir | Victoria | 3073 | Australia |
| Sheldon M Chumir Health Centre | Calgary | Alberta | T2N 0X7 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Entralogix Clincal Research Inc. | Brampton | Ontario | L6Z 4N5 | Canada |
| Entralogix Clinical Research Inc. | Brampton | Ontario | L6Z 4N5 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Entralogix Clinical Research Inc. | Oakville | Ontario | L6J 3M5 | Canada |
| N/A - formerly with Entralogix SMO | Toronto | Ontario | M4C 5T2 | Canada |
| Sunnybrook Health Sciences Center | Toronto | Ontario | M4N 3M5 | Canada |
| Centre de sante et de services sociaux champlain-Charles-Le Moyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Centre de Dialyse de Bois de Boulogne | Montreal | Quebec | H3M 3E3 | Canada |
| Hopital de Sacre Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| Saskatoon Nephrology Group, Nurses Redisence | Saskatoon | Saskatchewan | S7M 2Z1 | Canada |
| Saskatoon Nephrology Group, Nurses Residence | Saskatoon | Saskatchewan | S7M 2Z1 | Canada |
| Saskatoon Nephrology Group | Saskatoon | Saskatchewan | S7M 2Z1 | Canada |
| Aarhus Universitetshospital (Aarhus Sygehus) | Aarhus | 8000 | Denmark |
| Rigshospitalet | Copenhagen Oe | 2100 | Denmark |
| Steno Diabetes Center | Gentofte Municipality | 2820 | Denmark |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Division of Nephrology, Dept. of Medicine | Pokfulam | Hong Kong |
| Division of Nephrology | Pokfulam | Hong Kong |
| ICON Clinical Research | Quarry Bay | Hong Kong |
| Prince of Wales Hospital | Shatin | N.T. 0 | Hong Kong |
| Apollo Hospitals | Hyderabad | Andhra Pradesh | 500096 | India |
| Gujarat Kidney Foundation | Ahmedabad | Gujarat | 380 007 | India |
| Shrushrut Clinical Research Association | Ahmedabad | Gujarat | 380 013 | India |
| P. D. Hinduja National Hospital and Medical Research Centre | Mumbai | Maharashtra | 400016 | India |
| Pfizer Centre | Mumbai | Maharashtra | 400102 | India |
| Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra | 411 004 | India |
| Diabetes Care and Research Centre | Pune | Maharashtra | 411 011 | India |
| KE.M Hospital Research Centre | Pune | Maharashtra | 411 011 | India |
| King Edward Memorial Hospital | Pune | Maharashtra | 411 011 | India |
| Jehangir Clinical Development Centre Pvt. Ltd. | Pune | Maharashtra | 411001 | India |
| Universiti Sains Malaysia | Kota Bharu | Kelantan | 16150 | Malaysia |
| Unit Kajian Klinikal, Hospital Universiti Sains Malaysia | Kubang Kerian | Kelantan | 16150, | Malaysia |
| Hospital Taiping | Taiping | Perak | 34000 | Malaysia |
| Clinical Research Centre, Hospital Pulau Pinang | George Town | Pulau Pinang | 10990 | Malaysia |
| Hospital Pulau Pinang | George Town | Pulau Pinang | 10990 | Malaysia |
| Nephrology Clinic, Queen Elizabeth Hospital | Kota Kinabalu | Sabah | 88586 | Malaysia |
| Unit Hemodialisis, Hospital Serdang | Kajang | Selangor | 43000 | Malaysia |
| ICLE SC | Guadalajara | Jalisco | 44600 | Mexico |
| Comite Mexicano para la Prevencion de la Osteoporosis, A.C. | Mexico City | Mexico City | 06100 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ) | Tlalpan | Mexico City | 14000 | Mexico |
| Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Osteoporosis | San Luis Potosí City | San Luis Potosí | 78240 | Mexico |
| Hospital Angeles del Pedregal | Angeles Del Pedregal Cp. | 10700 | Mexico |
| NZOZ "DIAGNOMED" S.C., Poradnia Nefrologiczna | Bielsko-Biala | 43-300 | Poland |
| Samodzielny Publiczny Szpital Kliniczny im Andrzeja Mieleckiego | Katowice | 40-027 | Poland |
| NZOZ PS "Medica" | Lublin | 20-538 | Poland |
| Centrum Medyczne "Osteomed" NZOZ, Lecznica Specjalistow | Warsaw | 02-256 | Poland |
| Centrum Medyczne "OSTEOMED" NZOZ | Warsaw | 02-256 | Poland |
| Centrum Medyczne "Osteomed" | Warsaw | 02-256 | Poland |
| Centrum Medyczne OSTEOMED NZOZ; Lecznica Specjalistaw | Warsaw | 02-256 | Poland |
| Miedzyleski Szpital Specjalistyczny w Warszawie | Warsaw | 4749 | Poland |
| SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego | Wroclaw | 50-556 | Poland |
| Clinical Center of Serbia Institute for Endocrinology, Diabetes and Metabolic Diseases | Belgrade | 11 000 | Serbia |
| Clinic for Nephrology, Military Medical Academy | Belgrade | 11000 | Serbia |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Clinical Hospital Center "Zvezdara" | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Zvezdara | Belgrade | 11000 | Serbia |
| Clinic for Endocrinology, Clinical Center Nis | Niš | 18000 | Serbia |
| FNsP Bratislava, Nemocnica Stare Mesto | Bratislava | 813 69 | Slovakia |
| Nemocnice s poliklinikami n.o. | Levice | 934 01 | Slovakia |
| Fakultna nemocnica s poliklinikou J.A.Reimana Presov | Prešov | 081 81 | Slovakia |
| Vseobecna nemocnica Rimavska Sobota | Rimavská Sobota | 979 12 | Slovakia |
| Worthwhile Clinical Trials (WWCT), Lake View Hospital | Benoni | Gauteng | 1500 | South Africa |
| Dr. George Mukhari Hospital -University of Limpopo | Pretoria | Gauteng | 0204 | South Africa |
| Wits Clinical research | Johannesburg | Gauteng- South Africa | 2096 | South Africa |
| Centre for Diabetes and Endocrinology | Durban | KwaZulu-Natal | 4091 | South Africa |
| Latros International | Bloemfontein | 9301 | South Africa |
| Division of Nephrology and Hypertension, E13 Renal Unit | Cape Town | 7925 | South Africa |
| St Augustine's Hospital | Durban | 4001 | South Africa |
| Centre for Diabetes and Endocrinology | Durban | 4091 | South Africa |
| Centre for Diabetes and Endocrinology | Houghton, Johannesburg | 2198 | South Africa |
| Intercare Parow Medical and Dental Centre | Parow | 7500 | South Africa |
| Medi-Clinic Heart Hospital (Pretoria Heart Hospital) | Pretoria | 132 | South Africa |
| Pharmacy | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Clinical Trial Pharmacy | Seongnam-si | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Samsung Medical Center, Department of Pharmacy | Seoul | 135-710 | South Korea |
| Samsung Medical Center,Sungkyunkwan Univ School of Medicine | Seoul | 135-710 | South Korea |
| Samsung Medical Center/Division of Nephrology | Seoul | 135-710 | South Korea |
| Boramae Medical Center/Division of Nephrology | Seoul | 156-707 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| Sahlgrenska University Hospital Njurmottagningen | Gothenburg | 413 45 | Sweden |
| A+ Science City site | Stockholm | 111 57 | Sweden |
| Akademiska Sjukhuset | Uppsala | 751 85 | Sweden |
| Doncaster Royal Infirmary | Doncaster | South Yorkshire | DN2 5LT | United Kingdom |
| Research Offices (5th Floor) | Coventry | CV2 2DX | United Kingdom |
| University of Edinburgh | Edinburgh | EH16 4TJ | United Kingdom |
| The Royal London Hospital Whitechapel | London | E1 1BB | United Kingdom |
| Guy's and St Thomas' Foundation Trust | London | SE1 9RT | United Kingdom |
| Northern General Hospital Campus | Sheffield | S5 7AU | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to PF-00489791 tablet orally once daily for 12 weeks. |
| BG001 | PF-00489791 20 mg | PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12 | UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 12], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 12]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR. | Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/mmol | Baseline, Week 12 (Day 5, 6, 7) |
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| Secondary | Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16 | UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of specified Week], and with last sample collected on the morning of scheduled clinic visit [Day 7 of specified Week]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR. | Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/mmol | Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7) |
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| Secondary | Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16 | UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 3, 6, 12, 16], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 3, 6, 12, 16]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR. | Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/mmol | Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7) |
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| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16 | The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) = 175*(sCr/88.4)^-1.154*(Age)^-0.203*(0.742 if female)*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1). | Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Baseline, Week 3, 6, 12, 16 (follow-up) |
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| Secondary | Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16 | Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + ([systolic blood pressure - diastolic blood pressure]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart. | Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. | Posted | Least Squares Mean | 95% Confidence Interval | millimeter of mercury (mmHg) | Week 0, 3, 6, 12, 16 (follow-up) |
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| Secondary | Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16 | Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1). | Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | micromole per liter (mcmol/L) | Baseline, Week 3, 6, 12, 16 (follow-up) |
|
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| Secondary | Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16 | TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1). | Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | Baseline, Week 3, 6, 12, 16 (follow-up) |
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| Secondary | Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16 | The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1). | Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | milligram per liter (mg/L) | Baseline, Week 12, 16 (follow-up) |
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| Secondary | Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16 | Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1). | Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/L | Baseline, Week 12, 16 (follow-up) |
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| Secondary | Plasma Concentration Versus Time Summary of PF-00489791 | Pharmacokinetic analysis set included all randomized and treated participants with at least 1 measured PF-00489791 concentration. Here, "Number analyzed" signifies number of participants evaluable for specified categories. This outcome measure was planned not to be analyzed for Placebo reporting arm. | Posted | Mean | Standard Deviation | microgram per millilitre (microgram/mL) | Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6 |
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| Other Pre-specified | Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16 | Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months. Baseline HbA1c level was determined predose at Week 0 (Day 1). | Safety analysis set consists of all participants who received at least 1 dose of study medication. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | percentage of hemoglobin | Baseline, Week 12, 16 (follow-up) |
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| Other Pre-specified | Number of Participants With Vital Signs Abnormalities | Criteria for determining vital signs abnormalities: supine or standing systolic BP (SBP) (less than [<] 90 mmHg and increase or decrease of greater than or equal to [>=] 30 mmHg compared to baseline value), supine or standing diastolic BP (DBP) (<50 mmHg and increase or decrease of >=20 mmHg compared to baseline value), supine pulse rate (>120 beats per minute [bpm] or <40 bpm), standing pulse rate (>140 bpm or <40 bpm). For supine, baseline was the average of the triplicate predose readings at Week 0 (Day 1). For standing, baseline is the predose reading at Week 0 (Day 1). Only categories who had at least 1 participant are reported. | Safety analysis set consists of all participants who received at least 1 dose of study medication. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively. | Posted | Count of Participants | Participants | Baseline up to Week 16 (follow-up) |
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| Other Pre-specified | Number of Participants With Edema and Fluid Overload | Participants were assessed for signs of edema and fluid overload. | Safety analysis set consists of all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Week 0, 3, 6, 12, 16 (follow-up) |
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| Other Pre-specified | Number of Participants With Increased Use of Diuretics | Safety analysis set consists of all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Week 16 (follow-up) |
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| Other Pre-specified | Number of Participants With Laboratory Test Abnormalities | Criteria for laboratory test abnormalities: Hematology (hemoglobin [<0.8*lower limit of normal{LLN}], hematocrit [<0.8*LLN], red blood cells [<0.8*LLN], platelet [<0.5*LLN/>1.75*upper limit of normal{ULN}], white blood cells [<0.6*LLN/>1.5*ULN], lymphocytes [<0.8*LLN/>1.2*ULN], neutrophils [<0.8*LLN/>1.2*ULN], basophils [>1.2*ULN], eosinophils [>1.2*ULN], monocytes [>1.2*ULN]); Liver Function (total/direct/indirect bilirubin [>1.5*ULN], aspartate aminotransferase/ alanine aminotransferase/ gamma glutamyl transpeptidase/ lactate dehydrogenase/ alkaline phosphatase [>3.0*ULN]); Renal Function (blood urea nitrogen/ creatinine [>1.3*ULN], uric acid [>1.2*ULN]); Electrolytes (sodium [<0.95*LLN/>1.05*ULN], potassium, chloride, calcium, bicarbonate [<0.9*LLN/>1.1*ULN]); Clinical Chemistry (glucose [<0.6*LLN/>1.5*ULN], glycosylated hemoglobin [>1.3*ULN], Creatine Kinase [>2.0*ULN], Amylase, Lipase[>1.5*ULN]). | Safety analysis set consists of all participants who received at least 1 dose of study medication. Here 'N' (Overall Number of Participants Analyzed) signifies participants evaluable for this measure. | Posted | Count of Participants | Participants | Baseline up to Week 16 (follow-up) |
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| Other Pre-specified | 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 medication without regard to possibility of causal relationship. SAE: 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 medication and up to Week 16 (follow-up) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs) | Safety analysis set consists of all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Week 16 (follow-up) |
|
|
Baseline up to Week 16 (follow-up)
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 one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. AEs included both non-serious (AEs) and serious adverse events (SAEs)
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 | Placebo | Placebo matched to PF-00489791 tablet orally once daily for 12 weeks. | 1 | 64 | 6 | 64 | 35 | 64 |
| EG001 | PF-00489791 20 mg | PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks. | 0 | 192 | 13 | 192 | 104 | 192 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Prostatectomy | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Eye infection bacterial | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Mastitis fungal | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood pressure abnormal | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Electrocardiogram ST segment depression | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Liver function test normal | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Monoclonal gammopathy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Spontaneous penile erection | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neuropathic ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Immobile | Social circumstances | MedDRA 16.0 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 16.0 | 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 |
|---|---|
| D003928 | Diabetic Nephropathies |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000619499 | PF-00489791 |
Not provided
Not provided
Not provided
| Male |
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| Black |
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| Asian |
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| Other |
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| Change at Week 12 |
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| Superiority |
| ANCOVA model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic BP as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo. | ANCOVA | 0.2402 | Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than or equal to 20% reduction in UACR compared to placebo. | 2-Sided | Superiority |
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PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.
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| Participants |
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